Full text of "Unnecessary hysterectomies, the second most common major surgery in the United States : hearing before the Subcommittee on Aging of the Committee on Labor and Human Resources, United States Senate, One Hundred Third Congress, first session ... May 5, 1993"

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S. Hrg. 103-183

UNNECESSARY HYSTERECTOMIES, THE SECOND
MOST COMMON MAJOR SURGERY IN THE
UNITED STATES =^=^^=^=

Y4.L 11/4; S. HRG. 103-183

Unnecessarg Histerectonies/ the Sec. . . \jr^

BEFORE THE

SUBCOMMITTEE ON AGING

OF THE

COMMITTEE ON

LABOR AND HUMAN RESOURCES

UNITED STATES SENATE

ONE HUNDRED THIRD CONGRESS
FIRST SESSION

EXAMINING ISSUES RELATED TO HYSTERECTOMIES, FOCUSING ON THE
NEED TO BETTER UNDERSTAND THE CONDITIONS AND DISEASES
TREATED BY HYSTERECTOMY, THE PSYCHOLOGICAL AND FAMILIAL
IMPACT RESULTING FROM THIS TYPE OF SURGICAL PROCEDURE,
AND THE NEED FOR ADDITIONAL RESEARCH TO DEVELOP ALTER-
NATIVE THERAPIES AND NONSURGICAL INTERVENTIONS

MAY 5, 1993

Printed for the use of the Committee on Labor and Human Resources

U.S. GOVERNMENT PRINTING OFFICE
68-G67CC WASHINGTON : 1993 3

NOV 1 2 ^

l^^ai^gi^Rv

For sale by the U.S. Government Printing Om"e ' '^'''*"*'0"T"Cr>|^f ^T* ^ ,,
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 '''^flO"

ISBN 0-16-041440-7

S. Hrg. 103-183

UNNECESSARY HYSTEREaOMIES, THE SECOND
MOST COMMON MAJOR SURGERY IN THE
UNITED STATES ^=^=^_^

Y4.L 11/4: S. HRG. 103-183

Unnecessiri Hgsterectonies/ the Sec... ^/^

BEFORE THE

SUBCOMMITTEE ON AGING

OF THE

COMMITTEE ON

LABOR AND HUMAN RESOURCES

UNITED STATES SENATE

ONE HUNDRED THIRD CONGRESS
FIRST SESSION

MAY 5, 1993

Printed for the use of the Committee on Labor and Human Resources

U.S. GOVERNMENT PRINTING OFFICE
68-G67CC WASraNGTON

NOV 1 2 W93

1993 ^UbfCilVrtiM. ,

For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402
ISBN 0-16-041440-7

in DC 70407 '*"W^r.l

COMMITTEE ON LABOR AND HUMAN RESOURCES

EDWARD M. KENNEDY, Maeaachusette, Chairman
CLAIBORNE PELL, Rhode Island NANCY LANDON KASSEBAUM, Kansas

HOWARD M. METZENBAUM, Ohio JAMES M. JEFFORDS, Vermont

CHRISTOPHER J. DODD, Connecticut DAN COATS, Indiana

PAUL SIMON, Illinois JUDD GREGG, New Hampshire

TOM HARKIN, Iowa STROM THURMOND, South Carolina

BARBARA A. MIKULSKI, Maryland ORRIN G. HATCH, Utah

JEFF BINGAMAN, New Mexico DAVE DURENBERGER, Minnesota

PAUL D. WELLSTONE, Minnesota
HARRIS WOFFORD, Pennsylvania

Nick LittlefielX), Staff Director and Chief Counsel
Susan K. HattAN, Minority Staff Director

Subcommittee on Aging

BARBARA A. MIKULSKI, Maryland, Chairman
CLAIBORNE PELL, Rhode Island JUDD GREGG, New Hampshire

HOWARD M. METZENBAUM, Ohio DAN COATS, Indiana

CHRISTOPHER J. DODD, Connecticut DAVE DURENBERGER, Minnesota

HARRIS WOFFORD. Pennsylvania NANCY LANDON KASSEBAUM, Kansas

EDWARD M. KENNEDY, Massachusetts (Ex Officio)

(Ex OfBcio)

ROBYN LIPPNER, Staff Director
FREDERIC C. Shaw Jr., M.D., J.D., Minority Staff Director

(ID

r»»

^ow

CONTENTS

STATEMENTS
Wednesday, May 5, 1993

Page

Mikulski, Hon. Barbara A., a U.S. Senator from the State of Maryland 1

Ballweg, Maiy Lou, Milwaukee, WI, executive director, Endometriosis Asso-
ciation; Mary Anne Marchase, Arnold, MD, and Greta Eley, Cheverly, MD,

prepared statement (with an attachment) 2

Pinn, Dr. Vivian W., director. Office of Research on Women's Health, National
Institutes of Health, Bethesda, MD; Dr. Veronica Ravnikar, University
of Massachusetts Medical Center, Boston, MA; and Dr. George W. Morley.
Department of Obstetrics and Gynecology, University of Michigan Medical

Center, Ann Arbor, MI 22

Prepared statements:

Dr. Pinn (with an attachment) 24

Dr. Ravnikar 36

Dr. Morley (with an attachment) 44

Carlson, Dr. Karen, director. Women's Health Unit, Massachusetts (General
Hospital; Dr. Arnold L. Widen, vice president and medical director, Blue
Cross and Blue Shield of Illinois, Dr. Joseph Gambone, associate professor
of obstetrics and gynecology, School of Medicine, University of California
at Los Angeles, ana Dr. Gloria A. Bachmann, professor and chief. Division
of Obstetrics and Gynecology, University of Medicine and Dentistry of New

Jersey ^^

Prepared statements:

Dr. Carlson 66

Dr. Widen 70

Dr. Gambone (with attachments) 74

Dr. Bachmann (with an attachment) 90

ADDITIONAL MATERIAL

Articles, publications, letters, etc.:

"Unnecessary Hysterectomies, the Second Most Common Major Surgery m
the United States," May 1993, prepared by the staff of the Subcommittee
on Aging J25

"Hysterectomy at Illinois Hospitals," May 1990 109

"Hysterectomy at Illinois Hospitals," December 1992 Ill

an)

UNNECESSARY HYSTERECTOMIES, THE SEC-
OND MOST COMMON MAJOR SURGERY IN
THE UNITED STATES

WEDNESDAY, MAY 5, 1993

U.S. Senate,
Subcommittee on Aging,
OF the Committee on Labor and Human Resources,

Washington, DC.

The subcommittee met, pursuant to notice, 2:17 p.m., in room
SD-430, Dirksen Senate Office Building, Senator Mikulski (chair-
man of the subcommittee) presiding.

Present: Senator Mikulski.

Opening Statement of Senator Mikulski

Senator Mikulski. Good afternoon. I'd like to convene today's
hearing and apologize to our witnesses for my lateness. I was at
the White House for a meeting on health insurance reform and did
not want to leave the room while the conversation was still going
on. So I apologize for any inconvenience I have caused the wit-
nesses and so Took forward to hearing the testimony of each and
every one of my panelists.

Today, we are going to look at the examination of the rates of
unnecessary hysterectomies in the United States of America. I'd
like to thank all of you for being here, and I'd especially like to
thank our witnesses, who have taken time off from their own jobs,
their families, their medical and research practices to come and
testify. I know that in many cases, you will be bringing up painful
memories, and I salute your courage in coming here today.

This is the first congressional hearing since 1976 on this topic,
and we are going to spotlight and investigate a most disturbing
fact — the fact that hysterectomies remain the second most common
surgical procedure in the United States of America, and research
indicates that often it is too much surgery for not enough compel-
ling reason, and for reasons that are little understood, rarely evalu-
ated, and no real understanding of the mental and physical tolls
that it takes.

In 1976 when my predecessors held a similar hearing, Congress
investigated the rate of hysterectomies and found that between 24
and 46 percent of hysterectomies were not necessary. Now, more
than 15 years later, with the advancement of medical research,
consciousness raising among women, today's testimony will show
that at least 24 to 30 percent of hysterectomies are still unneces-
sary. This is not a satisfactory set of statistics. And we know that

(1)

behind every one of those statistics is a compelling story and a
compelling human need.

Our Congressional hearing today will show that nearly two dec-
ades of medical practice and research, have brought us no closer
to reducing the rate of unnecessary hysterectomies, no closer to un-
derstanding the causes and conditions that lead up to the need for
this procedure, and no closer to knowing if hysterectomies are ef-
fective in treating these conditions.

In reading the New England Journal of Medicine — and, yes, I do
read the New England Journal of Medicine — I read Dr. Carlson's
article that stated that after decades of performing hysterectomies
on women, there continues to be a professional uncertainty about
the appropriateness of recommending hysterectomy.

So today, this hearing is going to focus on a lot of questions. The
first is wny is there a lack of agreement among physicians about
the appropriateness of this procedure. Why is there so little re-
search into the diseases and conditions that lead doctors to rec-
ommend hysterectomies? And why are hysterectomies being per-
formed even though we don't know if they cure or contain the con-
ditions they are thought to help, or if they pose long-term health
risks for the women who get them.

We also know that women have a right to ask questions like
what is the cost — what is the cost to me, to my family and to my
life? What is going to be the cost to me in terms of how I will feel
about myself and how I will function? What is the cost in terms
of ongoing family relationships? And what is the cost to our family
health insurance bill?

And the United States has a role in asking the question: What
is the cost of unneeded hysterectomies to the United States of
America, to our Medicaid and Medicare budgets, and what is the
cost in terms of insurance companies?

It seems to me that if a surgical procedure is needed, then by
gosh, we have to get it. My dear mother, age 78 today, is alive be-
cause in this country, even as a senior citizen in her late 60's, she
had access to quadruple bypass. They said it would extend her life
for 5 years, and it has now been more than 10 years, and she and
I are going to have the best Mother's Day possible, and the best
Mother's Day is that we have each other.

So we believe in medicine, and we believe in high-tech medicine,
but we also believe that surgery should be based on compelling
human need in which all aspects of safety and efficacy are exam-
ined.

Having said that, I am now going to turn to our witnesses and
give them a very cordial welcome, because we believe that the peo-
ple who are the most affected should have the most to say.

We will turn first to Mary Lou Ballweg, executive director of the
Endometriosis Association.

STATEMENTS OF MARY LOU BALLWEG, MILWAUKEE, WI, EXEC-
UTIVE DIRECTOR, ENDOMETRIOSIS ASSOCIATION; MARY
ANNE MARCHASE, ARNOLD, MD, AND GRETA ELEY,
CHEVERLY, MD

Ms. Ballweg. Good afternoon.

Endometriosis is a disease affecting at least 5 million women
from all races and socioeconomic groups in the United States. It is
a nightmare of misinformation, myths, taboos, lack of diagnosis,
and problematic hit-and-miss treatments overlaid on a painful,
chronic, stubborn disease. And it is the fastest-growing reason for
hysterectomies in the United States, with hysterectomies for the
disease increasing by 121 percent from 1965 to 1984.

Moreover, endometriosis is leading to hysterectomies at younger
and younger ages — in females ages 15 to 24, there was a 250 per-
cent increase in the hysterectomy rate between 1965 and 1984, and
in women ages 25 to 34, a 186 percent increase. Even worse, hys-
terectomy and removal of the ovaries may not cure endometriosis.
In a study from the Endometriosis Association's research registry,
the largest in the world, hysterectomy provided no relief or cure for
about one-third of the women.

The Endometriosis Association, the first organization in the
world to provide direct assistance to women with this disease, rep-
resents millions of women who are routinely told their pain and
problems are "all in their heads" or "just cramps" or, if painful sex
is one of their symptoms, as it is for 59 percent, that thev are "frig-
id." Yet the same symptoms that begin "in their heads' are cause
for hundreds of thousands of hysterectomies and surgical castra-
tions each year.

There are obviously too many hysterectomies for endometriosis,
but not necessarily because of inappropriate treatment, although
there is some of that. The bigger reasons lie in an apparent in-
crease in the number of girls ana women with endometriosis, in not
diagnosing the disease early enough to provide the best opportunity
to slow it down, and in the lack of basic research so real treatment
options and cures could be offered.

I began the Endometriosis Association in 1980 because of my
own struggles with endometriosis. Like most, my symptoms began
in my teen years, but I was not diagnosed until many years later.
I suffered three bouts of disease so severe I was bedridden and be-
came so destitute that I had to go on food stamps to be able to eat.

Like many women with endometriosis, I tried every available
treatment £ind eventually had a hysterectomy and removal of my
ovaries. The hysterectomy did provide relief from the pain and al-
lowed me to care for my "miracle baby" rather than become bed-
ridden again, for which I was grateful. But, as it does for many
women, it caused severe surgical menopause and emotionally try-
ing sexual problems.

For 8 years after the hysterectomy, I suffered no more
endometriosis, although my baby daughter and I both suffered and
continued to suffer with some of the related health problems we see
in endometriosis. Then, when my estrogen dose was increased to
counteract joint pain, endometriosis returned, and I had my fifth
surgery.

Like other women with endometriosis, I also suffer from an auto-
immune thyroid disorder, and I have very severe osteoporosis, most
likely the result of the early removal of my ovaries.

Multiply my story by millions, and you will begin to understand
the suffering occurring because of this disease. Why are there now
millions with this puzzling disease when there were only 20 reports

on it in the world literature before 1921? Rather than blame
women, as some in the medical establishment have done, by stat-
ing without any scientific proof that the disease is due to postpon-
ing child bearing, we have been able to document a strong relation-
ship between environmental pollutants and development of
endometriosis.

In a rhesus monkey colony exposed to dioxin, 79 percent of the
animals developed endometriosis. In addition, the severity of the
disease was directly proportional to the amount of dioxin. A study
by the Canadian Federal government found that rhesus monkeys
developed severe disease after exposure to PCBs. These and related
toxins have been disseminated widely in the environment only in
recent decades and could well account for the unprecedented in-
crease in endometriosis.

But why has it taken women with the disease to learn this? Why
are women with endometriosis still forced to choose hysterectomy
as a necessary but very unfortunate "option"? We all know the an-
swer to that. If there were 5 million young men who faced ongoing
pain, the inability to become a father, the likelihood they would be
greatly hindered in pursuing a profession or income, routinely

Eainful sex, and ultimately, surgical castration, I wouldn't need to
e here today pleading for more research and options besides hys-
terectomy.
Thank you.
[The prepared statement of Ms. Ballweg follows:]

Prepared Statement of Mary Lou Ballweg

Endometriosis is a disease affecting at least 5 million women from all races and
socioeconomic groups in the United States. It is a nightmare of misinformation,
myths, taboos, lack of diagnosis, and problematic hit and miss treatments overlaid
on a painful, chronic, stubborn disease. And it is the fastest growing reason for hys-
terectomy in the United States, with hysterectomies for the disease increasing by
121 percent from 1965 to 1984. [1]

Moreover, endometriosis is leading to hysterectomies at younger and younger
ages. In females aged 15 to 24, there was a 250 percent increase in the hyster-
ectomy rate between 1965 and 1984; in women agea 25 to 34, a 186% increase. [2]

Even worse, hysterectomy and removal of the ovaries may not cure the disease.
In a study from the Endometriosis Association's research registry, the lai*ge8t in the
world, hysterectomy provided no relief or cure for about one-third of the women. [3]

The Endometriosis Association, the first organization in the world to provide di-
rect assistance to women with this disease, represents millions of women who are
routinely told their pain and problems are "all in their heads" or "just cramps" or,
if painful sex is one of their symptoms (as it is for 59 percent), [4] that they're "frig-
id. Yet, the same symptoms that be^n "in their heads" are cause for hundreds of
thousands of hysterectomies and surgical castrations each year.

There are obviously too many hysterectomies for endometriosis, but not nec-
essarily because of inappropriate treatment, although there is some of that. The big-
ger reasons lie in an apparent increase in the number of girls and women with
endometriosis, in not diagnosing the disease early enough to provide the best oppor-
tunity to slow it down, and in the lack of basic research so real treatment options
and cures could be offered.

I began the Endometriosis Association in 1980 because of my own struggles with
endometriosis. Like most, my symptoms began in my teen years but I was not diag-
nosed until years later. I suffered three bouts of disease so severe I was bedridden
and became so destitute that I had to go on food stamps to be able to eat. Like many
women with endometriosis, I tried every available treatment and eventually had a
hysterectomy and removal of my ovaries.

The hysterectomy did provide relief from the pain and allowed me to care for my
"miracle" baby rather than become bedridden again, for which I was grateful. But,
as it does for many women, it caused severe surgical menopause ana emotionally-
trying sexual problems. For 8 years after the hysterectomy, I suffered no more

endometriosis althou^ my baby daughter and I both suffered with severe allergies
and gastrointestinal problems that are typical in endometriosis. Then, when my es-
trogen dose was increased to counteract joint pain, endometriosis returned and I
had my fifth surgery. Like other women with endometriosis, I suffer from an auto-
inmiune thyroid disorder. And I have very severe osteoporosis, most likely the result
of the early removal of my ovaries.

Multiply my story by millions and you'll begin to understand the suffering occur-
ring because of this disease. But why are there now millions with this puzzling dis-
ease when there were only 20 reports on it in the world literature before 1921? [5]
Rather than blame women as some in the medical establishment have done by stat-
ing, without any scientific proof, that the disease is due to postponing chUdbearing,
we have been able to document a strong relationship between environmental pollut-
ants and development of endometriosis. In a rhesus monkey colony exposed to
dioxin, 79 percent of the animals developed endometriosis. In addition, the severity
of the disease was directly proportional to the amount of dioxin (p<0.001 using AFIS
and rAFS classifications of disease). [6,7,8,9]

A study by the Canadian Federal government found that rhesus monkeys devel-
oped severe disease after exposure to PCBs. [6] These and related toxins have been
disseminated widely in the environment only in recent decades and could well ac-
count for the unprecedented increase in endometriosis. [10]

But why has it taken women with the disease to learn this? Why are women with
endometriosis still forced to choose hysterectomy as a necessary but very unfortu-
nate "option"? We all know the answer to that. U there were 5 million young men
who faced ongoing pain, the inability to become a father, the likelihood they would
be greatly hindered in pursuing a profession or income, routinely painful sex, and
ultimately, surgical castration, I wouldn't need to be here today pleading for more
research and options besides hysterectomy.

REFERENCES FOR HYSTERECTOMY FOR TESTIMONY

1. Hysterectomies in the United States, 1965-84. Vital and Health Statistics, U.S.
Department of Health and Human Services, Public Health Service, Centers for Dis-
ease Control, National Center for Health Statistics, Series 13, No. 92, 1987.

2. Berger, Gary, 'Epidemiology of Endometriosis." Modem Surgical Management
of Endometriosis. (New York: Springer- Verlag Publishers, 1994)

3. Lamb, Karen, Breitkopf, Lyle J., and Karen Hamilton. "Does Total Hyster-
ectomy Offer A Cure For Endometriosis? An Exploratory Study." Endometriosis As-
sociation Newsletter, Vol. 12, No. 3, 1991.

4. "Characteristics Of Women With Endometriosis." Endometriosis Association
Newsletter, Vol. 10, No. 2, 1989.

5. Older, JuUa. "Leeches and Laudanum: Grandmother and You; Historical High-
lights." Endometriosis. (New York: Scribner's, 1984)

6. Ballweg, Mary Lou. "Research News: Endometriosis Linked to Radiation and
Environmental Pollutants in Research Studies." Endometriosis Association News-
letter, Vol. 13, No. 2, 1992.

7. Ballweg, Mary Lou. "Research News: Exciting Findings in Dioxin Monkey Col-
ony." Endometriosis Association Newsletter, Vol. 13, No. 3, 1992.

8. Ballweg, Mary Lou. "Dioxin Danger in Tampons: How to Obtain Safe Sanitary
Supplies." Endometriosis Association Newsletter, vol. 13, No. 3, 1992.

9. Rier, Sherry. Research News: Immunological Findings in Dioxin Monkey Col-
ony." Endometriosis Association Newsletter, Vol. 13, No. 4, 1992.

10. Ballweg, Mary Lou. "Dioxins, PCBs, and Endometriosis — What Do We Need
to Know to Protect Ourselves?" Endometriosis Association Newsletter, Vol. 13, No.
4, 1992.

rrMDOMETRIOSIS
*y\SSOCIATION

Education Support Research

tnlxmallmal Handquanwt

8585 N. nilh Pile*

MllwtukM. Wl S3223

FACTS AND FIGURES ON ENDOMETRIOSIS

What II Is: Tissue normally In the uterus li (Iso found In Ihe .ibdnircn, on the ovaries ind abdominal lining,

boivrl mid bladder, resulting In Internal bleeding, formation of scar tissue. Inflammation, and other

mcdifol prul'lems.
Number jffecled In U.S.: 5 milllnn Number affected in Canada: One-half million

Age disease alrllies: 11-50 years
Rjces: All
lncon<F groups: All
Symplomn;

Chronic pelvic p.iln

f^l^.ilillnj; prrlods

lncie.i':lnf,iy p;ilnlul menstrual periods

Ri'pr.iird miscarriages

t'ain vvllh sex

Infcrllllly

Irrrpul.ir nicnslrunl cycles

f\llnliil bowel movernrnt5 wllh period

I'alnlul urination or urinary problems wllh period

Clunnlc fatlpur

Loiv resistance to Infrc'lons •

P.xleniivr atlriglcs ind rclntrd prol'lems
Dlignnils: Laparnscopy (minor surgical procedure)
Cause: Unknown. Theories Include:

Genetic

Autoimmune disorder

Rctrcp/ndc menstruation

Pirth delect

Lymphatic or circulatory distribution of endometrial (Issue
Treatment:

Surgery — variety of traditional surgeries and new laser techniques lo remove the endometrial growths.

(jnforliinately, the disease nimpnl always returns.
Ilnrmnnal — v.irlcly nl female and mate hormonal preparations are used In attempt to cause the disease (o

rrgiesi and waste away.
Pain nicdicallnns — variety of p.ilnV.llters from over-lhe-rounler to the most potent narcotics are used for

the pain t>l endometrlcftls which can range from mild lo excruciating
Cure: Nrne. When e«treniclv disabling, hysterectomy and removal of the ovaries (caslralion) are performed

as a last resort bul Is generally unacceptable due lo the young age of the girls and women Involved and

lllclnng altering effects.

Trngrams of the Endometriosis Assoclallon;
Support —

Suppiirl f;riuips and chapters for sufferer* and their famtllet

Crisis call help

A.'sslstance via correspondence and networking
Education —

Accurate. Informative literature

Newsletter with research news, coping help, lips

Educational programs and mailings; assistance lo media
Research —

Continuous data gathering, analysis, and publication

Technical assistance fin researchers

Compiilerlr.ed data registry for research

The Association has members and afllllates across the U.S. and Canada and works wllh Ihe public and
medical ronimunlly In addUlim to those wllh endometriosis and their families It Is a non-profit organliallon
with IRS designated 50l(c)3 status — all donations lo Ihe organization are tax deductible.

Cfirififcrs fr Siii'iKnl Cri>ri;K. Cfi<;.< Cull fli/ji. Mcdictit Rc<enrch & Dnia Renislry. fntl Sfiirls & BrorfiKrr-s,
Nniflclirr, kdiiciilitm Pri»(riiiiii, liiforinnlion Clenrinyliouse, Techiiiail AssMnnce

FA 103 ""/"

I;'fMUOIVIETRIOSIS
-Association

EducaHon Support Research

Intprnadcnfll HB<-idqijarteis
asas N. 7nui pik*
Mitwauti**. Wl $3223

DOES TOIAL IIYSIERECIOMY Ol F F,R A CURE FOR ENDOMETRIOSIS?

An Explorntoi7 Study

BY: Kartn l.amh, UN, Fh P., Diicclor, EnrtomcliioiU Afsocintiim Rc.\ennh Rcgisir)' and Pitecior, Vihiien Family Health
program; Lyic J. nreiiknpf, H.D , Diicclor of llie Endomclrins'u Clinic, Beehnan Hoy>iial, New York City and Assistant
Clinical Profrs^nr, New }'ork Dnivcrsiiy School of Medicine; Karen Hamilton, MT (ASCP), medical technician artd medical
student at the Medical College of Wisconsin,

He d liltr to Intc this o/'pnriimil)- (o t^rerinlly ihnnk our
member, Knren llnmihon, who vohwiccinl in niiiti Knrrn
Lnmh tA-ith ihh ^tii'ty tind ntUer wmi inwh ing the reirnrch
registry. Ilrr help not inxahiohlel KnttK llnmiUon has since
thai time gone nn to medirat sriiool at the Medirat College of
(Vi'.tron.ii'n and hv 're sure thai she will be a »r>nderfUI
physician.

• • • •

Editor *.T nntr: micH the Association hcgnn, it was com
mnnly noted in the medical community that hyxlerecinmy and
rcmovnl of the ovaries resulted in n ciiie of cndomeiriosi' In
95% or more of ca\es. H> were stirjtrixed then ihaifiom our
earliest days there seemed to be so many women who hnd had
this proredure "ad stitl had enda. A few years ago, I osVrd
Knren Lamb, UN., Ph D who has long been associated with
our research ref^inry, to explore the question ofuheiher
hysterectomy and nmnwl of the ovaries cored endo, iiiilitiag
the registry, .^he did and we're pleased to present her study
here. Tfie srtid) is wt itten tip in scientific language — we 'i*r
tried to provide definitions and ejjilanations to help readers.
The information presented here is so important that we fell
members wotdd want it in .rpite of the technical language.

This first-ever study must be viewed as a preliminary one. In
that it raises as many questions as it ari.nver.x. One question Is
whether more women would tutve had a .Mtrces.rful outcome If
disease on the lum el and bladder had been removed. Tliere
tvere a large number of women nith howeh'hiadder Involve-
ment in the stiuty. At the lime of the study, and all too
. commonly now, it has been typical to leave the dhease
behind on bowel and bladder.

Tragitally, ihf hnwel and bladder tnt oU-rmcni may have
been the reason for many of the y^rjmcn going to hy.Mcreclomy
because other Ireatmenlr available up until recently did not
address disease ofthe.\c areas very well. Only rerenilv have a
few surgeons developed good techniques for removing endo
of these areas Tor more on surgeries for endometriosis {not
hysterectomy) .tee the Surgical Collection. For more on
bo»fl ini-nhemeni, see our .special article "Endo and Ttie
Intestines ' For mo'e on endometriosis involving lite bladder,
.tee Vol. rt, No. I of the newsletter.

If you want more information about ihii study, listen to the
audiotape pretcniaiion by Dr. Lamb and Or. l.yle Breitkopf
available in the 10th Anni\xrsary Conference Audiotape set.
{The set, 23 sjJcaters on 7 caxsclles In a prrmoneni siornge
binder. Is availnhle from headqunriert for JJ5 U..^.lH2.70C.)

Acknowlcdeementr; Ihjs study iva\ funded w'ttlt philan-
thropic awards from Ms Tracy II. Dickinxon, New Jersey and
CeorgAnna and Joseph Vihiein, Jr., Wisconsin.

INIRODUmoN

The U.S. Ni4lnn>l Crnlrr Tot Mcillh SlilMiu' reroili ihout I2J
mitlion liyslcrcrlomlc' wrrr conducted between 1965 ind I9M.
or 97 million renijle.'< a(;rd 15 yein and older, illve In 1985,
ipptoxiinalely 19.5% hsd undcrgnne hy^lcrcclomy. Roughly
670.000 hyMcrerlninlc5 were petfnmied in fBS.

Between 1970 and I9R4, cancel acrounled for I0.7?t of all
bynlercclnniic5; fihrrlds was Ihc mant common diagrosK, an
(sllnuted 21% of all hy.^lciccloriiies. Endoniclrio^ls accounlcd for
M.7%. Aniong all dligno^es, only endomclriosb demonstraled •
sharp lncrca<:r: • |2t pcicentagc overall Increase between 1965-67
and 1982-P'l (CanceTand fihroida Increased 2.1 and -7.2%
respectively)

Allhciur.h bilateral nophnrecloiiiy |reinoval of the ovarlcj is
rclitivrly unconiinnn, .105,01)0 ptoceJutes were pcrfnmicd In 1984,
88.5'J!' peifotincd In cnnlum lion with hyslertclomy. Data were
not icpoftrd .specirUalh' for enJornetrio.^1^.

Several reasons were prstulalcd for the dramatic Increase in (he
nunil'cr of hysteirctomir-s for endometriosis. The aulhon specu-
lated tbsl endometriosis iiiiy br more common, or severe, as
women drUy chlldhearing and the use of oral contraceptives falla.
While the prevaleni e may not have Inctrased, Improved technol-
ogy, nolal'lv use of the l>|i»ro5ciipr, has led to improved diagnosis.
Finally, the authors noted changes in medical practice — and, as
examined here — most notaMy physicians' willingne.vs to perform
fcy.stcrcctoniy may arcounl fr>r rale changes (Prevalence, In
epidemiology, is the number of all new and old casts of a disease
or occurrences of an event during a particular period of lime )

Ihe rnnrnious variation in surgical procedures for endonietriosia
has tKen refencd to as a "blue plate special". Caulrrbation,
mic ro surpiral dissection, laser surgery, removal of implants and
adhesions, and excision of endomelri.Tl cysts are a few descriptions
applied to the procedures perfornrd. (Tor more infornuHon on
these priicrdures. see our Suigii al Collerlion.) For many patients,
no jurj;ery carries mure anaiely than the one proredure believed Is
offer a cure: total hysterectomy, TAll/DSO |toUl abdominal
hysterectomy /liilateral salpingo-oophoreclomy-removal of Ihe
(terus, fallopian tubes, and ovaries|.

Cnnunon medi> al piaclice uses estrogen replacement. The
question arises »s tn whether hormonal replaccincnt to offset
lurgically-induced iirrnopause causes a rc« urrcnce of cndome-
Irtosis or cndomclriosis-lile syiuffloms. A review of Index
Medlrus \'i\ index of medical and research )ournals| (1984-1987)
showed no assessment of recurrence rates with cstrop,i-n adminis-
tration; a compulerired search spanning 1966-April, 1989, yielded
no arvswers.

Ouestlon.s raised include: Are there factors in the natural history
characterising patients proceeding to hysterecttmiy? Related to
estrogen replacement therapy (ERT), does estrogen used alone, or

(continued on next page)

lnrniiiMit«lli'ii >vllli I'li'pr^lrinm . alfii I «iiipli «l ouU niir?

Fxlon In llir nuliinl bUliitv im lvnl< thr n<i ntfrmr of
lU.v^iol »yiii|ilnm^. indiiiliiipdy^iiirimirhn ||uin «nJ "Ihn
syntptoin^ wilh tiirnN(ni.it pc fl<H)s| nm\ prlv it fain; «nd di^«MI-
lly, llic Insliilily In |Kif"tiii rmillMr i)»ily fum linn< McdirtI
lirnlmrnl with JamznI. nul mnlmrpllvrs (OO), «nd/oi
iuigli il Inlrrvcnliim ptliit In hy^lrictli'fny wctf conipirrd
hflwcrn gipup<; «nd. p«Hrn(<' c«prricnrc» with tiysltttclomy,
with tnd wilhnul ERT, were cvalualcd.

MF.IIIODS

Thr «titdy gioup wa« cotnp<i»rd of pallcnK liavlnR ^y^lfrec-
toniy for rndoinclrlosK Kcf king as^Kta nee from Ibc I). S.-
Canadian Endomclilmis A.<»oi iali'in fiom I9ROR7. |Pr<ausr of
Ihin lime fiainr, many In Ihf sluily wrtf lieairtf with danaml, (he
m<is* cotnmonly osf n huiitvtnal licalmcnl il the lltiie. lite
C.nRII drug;* (Syn'irl and l.upron) were not yel available. |
Many enniplalnrd Ihal riidnrnelrimia had reeurrtd, or Ihey had
eaptrlenced a relurn pf symploms.

The dalt rrgi.ilry of Ihe As.nncialion l« housed al the Mediril
Oillegc nf Wi.tcon.^ln. Ihe .lorvey In^lninienl rnven medical,
anrglral, pre^jnaniy and psychosocial Infoiriialion. Appro«l-
malely ifXXI • »se hlslorie« have been furnished by lome
members and have l>een analyzed.

Tor pallenis having had hyslereclonilej. illrnllon focused OB
Ihe queslions: If ynu had a hysterei lomy, did you receive
(sliogen replarenicnl therapy? Did surgery relieve or cure Ihe
endiinielriosis? If HRT was used, have you experienced any
return of symptoms 7

necau.se of the ralrgori< al nnlure of re.'-ponses, data were
analyzed, primarily, using Chi Square (X') measures. ♦

T.Mi 1. r>f:M<K:iiAiiiic ciiARAi.ni Risnts of rATiEurs wini
r.NixiMrinKisi!! luviNn in»irnr/-mMiFS (N>iiii

Alt' nf Respondenll 3«.»

Mltrird

While rnc(/clhnl< l<y
(iiltcfie cducaird
Median family Income

years (j - 7 1 yn)

Ehc^i (H)

70 4

«2«

».2

llyileieclomy SUKM

rufogrn Replacement (rRT)

No fini

IS!

14 8

N - numt»er of patients a ■ standard deviation

RESI'LTS

11)e data sel consisted of Z.fiSS palienLs who have undergone
laparoscopy or tspariitoiiiy; received Tirm diagnoses; and for
wlH'tn roniplele ticmogtaphic data were aviilabic Of these.
238 (9.0%) had hyslereclomies, illhough 43 (18.1% of paltenU

■When the reader eanmlncs an array of data, a picture of t»o events
(pt variables) iKcuning tugethcr. one aUays asVi; liow oftrn ould ihia
pi< luie have simply iKcuned by chanie alime? Chi Square la a mrasute
of statistical slRnirnanir or a meiaure of ptotwWIity; the picliaMlity of
this picture iKcmtcng by clianc. I or eaatnpir, a Chi Square ptobaWIily
value ■ p" of n nt InJicsIrs that Ihe •picture" (Ihe rtlitlo'isliip l>et»'een
Iwoormiwe variables) C'uldliavc .« i imeJ I out of trx) limes based on
chance alonr. Ibis result, which would !«• prelly rate, Indicalea to the
Invesiljjtiir thai "inmethlng" Is happenlnfj here that Is pobjHy na!
hsscil on ch.">nce al>*oe

In lliis jiuily. wc h.ive rilrd the sclual vilue ol Chi-.Square and Ihe
d t (ile{tees of frceil<.in) the lay rr.ij.f can disregard these numbers.
Whil one eonliniics to ncrj to f<«^|is >"< is the 'p salue, the ptobal-ility
■hat this eveni could have oiciirrcJ by ihance. A "p" value <i( less than
0 05 Is considered statistically aigniricant, rarely occurring by chance.

havit\g hy.li rcclornii s) did not have Ixrih ovaries lemoved aixl
were thciefoic not subject to ERT; parts of any ovary were iiol
removed in 7 cases (2.9r!i).

for Ihe rriiiaininp. IK9 pallenis (7.1%) Ihe uteres, both
ovaries and fallopian lulics were ictrKivcd. Of these, 161
(R.';.2'^) received ERT; 28 (14.8%) did not For brevity, the
tludy group consists of these rjses and arc refcned lo «s Ihe
hyslercclnmv group. II VST OR or H YST patients. Estlogcti
tcplacenieni therapy is abbreviated ERT; NO ERT Used for ill
abienee.

Respondents' agi s avciaged .16.8 years; range: 21-62. Seven
of 10 (70 ■ITo) were married; 38 2% were college educated.
The median family Income wis $35,000 per year.

Fxainination of demographic variables brhveen Ihe II YST
GR and remaining registry patients showed no stalislicalty
lignirii ant dilfercnccs in any demographic variable except age.
II YST fiR patients were older: 36.8 years vs. 31 5 (X') «
112.241; d.f. = 3;p I <OOI)l). For hysterectomy pallenlj,
there was no relalloitship between age and educational (lalui,
tiorany statislital telalioaship between whether a womiii wai
married and Ihe age Ihal bystcreclomy was perfoimed.

The Seserlly Imlei

Lading data on size of implants and extent nf adhesions, a
liniple Severity Index (SI) based on Acosla's and his col-
leagues' criterion of endometriosis Involvemenl of the urtnaiy
bladder and/or (nteslinat trad was devised. In other words, If
the patient had endo fif thr bladder or bowel, they were classed
IS having severe disease Dy Ibis mcssure, patients undergoing
hyslctectnoiy were more seriously ill (Tabic 2). Almost 62%
of the II YS r OR were characterized as having severe endomet-
riosis by virtue of bowel and/or bladder involveniciit vs. 36.1*
of Ihe icmaining registry respondents (X') ■ 48JI2; d.f. • t;

p.<omi).

T>U« 1. SF.VERIIA lnm.X BASKO ON UI«U<ARV BIjSnnF:"

ANn/OR IhTTESnNAt.lNVOLVKMKNT

Registry
llyii Patients Retpondenla

(N-IM)' (N-2393)'

L & L Jl

Severe — madder ll« «l 7 8«5 M.I

A/or flowel Involvement

I.r.ss Scv«ue — No
tlladder A/or Rowel
Involvement

31.3

ISU

(3.t

• Mining, (n in)

• Missing -7J(2.7'»)

f • frequency or numlx-r of patient!

X'-4l.3IZ:d.r •l;p-<O.00l

Tlse Nulurnl MIslory

For brevity, patients' s)mplorn.s, painpronies. and disibilily
levels from patients' case histories are not Included in l»ble
formal. Ilnwcvct, examination of data on the IIYST GR vei*u»
remaining repistry patients showed 8 of 1 1 symptom romplexe*
demonstrated stalislically significant differences. (X' probablH-
lies range between 0.02 and n.OOl )

Striking were the proporlioas in both groups experiencing
symptoms, yet In every instance, eucplingcompljinis of infer-
lilily, Ihe IIYST GR denionstralrd higher rates For example,
Ihcy offered more complaints of dysmenorrhea and pelvic palti;
fatigue, exhsuslion and low energy; dyspareunia |pain with
sex|; nausea and gastric upset al menses; complaints of low
grade fevers; low resistance lo Infection; but lower r»les of
Infertility, as noted.

F.tMlnmelrlnsIs Assnchitinn

All II VS r palii'iil^ tc|i(>ilrtl syiiipli.iiis |>tiiir In <)i.i|;ninK
(2 "''^ uf irpisli) pKlirnls rriwirirJ nn jilivsiol syniplniin)
Sympl'ini oniplixrs: hrnvy oi irrcgiiUt hircdinp; diTtinaf
• nJ/ot lic«tl»ilir: tti»irhc», pjlnful l»)».rl imivriiirnU, or nihcr
inlritlinal u|KrU «ilh nicn^rs were mil «l«thlii«lly difTf rtnt.

The Scvnily Index wm nnrrlali d lo nioM fyniptoni
ri'iiiplr«c«. llo«rvci, mmp!»inU of Infnlilily (p = 0.05);
hliguc «nd low rnctpy (p = 0.02); ind syinpli'iii coniplrx:
di>rThc», p«inful bowrl nmvciiirnis, «nd nIhcr lnlc«tin«l upsrH
(p 1 <0.0<I2) «ric !tl«li<lkiilly dilfntnl. The Ullrr, pcihsp.^ 1
linilc'liif;y (nrrdlcs^ tcpctilinn), could be t«pc< led lo coirrlile
with howrl/Mnddct Involvrnitnl. All were in the txpeded
dirccllnn.

The ni«|>itily eif l»'lh p.tiiiipf c ninplarncd fif piin Ihiiughoul
(he meiulnial ryiic, nol dimply il nirnes (p = 0 02). Hn\».
ever, IIY.";T pallciiK fell mote heivily Into this rilegoty. So
loo, Ihrsr palicnl.r < li^^lfied p»in Irvcl5 i« mote «evete (p »
<0.()0M. Ihe Severity Index wn^ unfilled lo p»ln profilri.

DU«l>llily me«^uir< showed IIYS T pjlimH weit
Incflpiicitiired lonpcf. Poib Ihr prrtpnrtlon di%ibl*-d, ti well ii
Ihr lenplh of lime dl^xMrd, f»rg<i<g from d«y' lo wrtlj, were
.tltlitlirally signifii inl al Ihe O.Ol prul<abilily level, ni IcM.
The Severity Index waa unrelated to Ihe exicnl of dbabilily.

Trenlmenl before Ily^ferTclomy

Provotalively, fcwrt IIVS1 piiifrb had beenltriird Kith
dani7n! fDanoctine) Of 189 II YSTpaticnH, only "»l (4R.I%)
had o^ed dana7ol vt ICIO (r'5..1%) of 24«6 registry paticnlj
(X'r 22d4;df. = l;p = <0.nOI).

Apptoxiniately 2 of 3 palirnU in Ih"- lerj'liy have been
treated with danarol; kaa than half of Ihr II YST CR viete
treated. Thr vari'Mc, Time on dana'ol, shnurd a trend for
IIYS f patients to have u«ed dana'ol fur ^hotter p'-rlodi. how-
ever, re»iilt,'» i»tre nut jl.itlstlcally dlffrreot. f Ihe Scvetlty
Index was mil related to this variable, nor lo the length of
litnc sinte hysterectomy waa performed, nor lo age at
hystetectomy )

ReraiKe of the Iniplleation that tlYSl pallent.t had had le«
medit al therapy used, a thorough examination of events
surrounding hystcreclcmy «as conduiled. rarliiutar Interest
lay In patients' ages al hystetectomy; Ihe lime between diig-
n<'sis and hysterectomy; and Ihe IrealnienI modalltiex used
before hystcrectttmy.

Results showed the time iKlwren diagnosis ind hysterec-
tomy averaged 2."»R 4 ■1.27 years" (IP4 rairs) Diagnosis
preceded hysteri rtomy for sonic by 1 1 to IR years. Yet, and
more Itiiporlapily. >t least 37 (20.1%) were diagnosed ilmid;
laneoBslv with removal of Ihe uterus.

Dlngnosls nt flyslerecloin*: ("nse flescripllons

Of 37 patients di:ignosed at hystcreelMmy, 27 (73") were
classed isilh severe disease by virtue of bowel and/or bladder
Involvement, perhaps Justifying hysteret tomv In the eyes of
many rrai lilioners. Icn (27';i) were classed as less severe.
Illsliirlrally, none of ihe 37 had had prior surgii al or medical
treatment, incl"iling use of OCs Severe rises' ages ranged
between 28 56 (Mian = 3a.l4S; ♦ 6.34);*»« Ihe majority
were In Ihi-ir 3tts and iOs.

Among to patients classed is less severe, ages ringed from

21 to «2 (Mean = 16 I;.* 12.34), Three were 21. 24, and 25.
None had teecjvcd prior medical/surgical intervention. None
rrpotti d bowel or bladder involvement. We classed these »
questionable suigcrics.

Annmali'usly jdeviation from what Is regarded as noimal), 2
casts were diagnosed sinmltaneoiisly al hysterectomy, but both
had ptioi treatment. One, a 2R year old, had had several surgeries

■ nd dan>7ol piesctibed. yet diagnosis remained elusive. A 36
year old had a piior surpiry; both had bowel/1>ladder Involvement.

An additional 4 cases, diar.nosed at hyslercttoriiy, had used
only oCi, however, Il could not lie determined if OCs were used
for pscuilo pregnancy or pregnancy prevention. No other
modality had been used; all were between 34 and 39; yet only I
was classified as having severe disease.

For thoroughness, sve examined 16 cases (R 7% of the HYST
OR) that, while there haibcen a lime Interval between diagnosis
• nd hyslctct lomy (nionilis to years), none had received Ircalmenl.
Six had bowel and/or bladilcr involvemcnl; 10 were classed «s
less severe. Summariring 184 cases, al least 37 (20.1 ft) and,
perhaps as many as 43 (23.4%), were diagnosed at Ihe time of
hyslerertomy, markinr; the extent of under-diagnosls of endnnx-
triosls. An additional Ki (R. 7%) were not Itcated. Importantly,
•he remaining 125 (67.9%) patlenLs with hysterectomy received
diagnosis of endometriosis prior lo hysterectomy and did receive
medical and/or surgicil intervention before hysterectomy.

Extent nf Meillcat Ihernpy

An analysis of 175 patients, for whom all data were available,
examined use of medical iii'idalilics: 'iral contraceptives,
dtna/ol, K'th, or neither. Almost hall (48.9%) of 45 patients who
had a hysterectomy al apes younger than 30 had used both drugs;

■ n additional 24 4% had been treated with danazol; 22.2% had
irsed only OO. Two (4.1%) had used neither.

for 130 patients, ag. d 30 or over at hysterectomy, 30% had
used both dan<rol and OCs (v». 48.''% of patients under 30); 10*
had only used dana7ol. Over I In 3 (35.4%) had simply used
OCs, and 24.6% used neither (X' - 17.318; d f . = 3; p ■= <0.01).

The Severity Index revealed hif;hrr percent.tgcs of patients
nndet Mi Itealed with danazol, or dana7.ol and OCs: 74.1 ind
72 I % for severe and less severe categories, respectively (Table
3). Percentiiges fell diamatit ally for patients operated al 30 and
older: 37.2 vs 44.2% In Ihe severe and less severe categories, re-
ipet lively. Plill, for patients 10 and older, ab<iul 4 In 10 were
reached with d«na7ol therapy (X' • 20.575; d f . - 9; p - <0.02).

•*TV itMi^l Innrftinl nwrnt'tt tot tht Uy teadrt lietc Is Itic tt*llok*t mraa M
"•vttafr '. wKli K It Ihr Rt^l *wnitt.-r.

•• •the (»io*l lnir.<'tljn( Runil-tt In t'»cl» on Is Ih'" tnt»*l O' awenf*. TKr
nii'nt.rr tollo« lii| <lif ftu' ni minus tefrts (n Ihe il^iHlwd drvlsilon i%t
tfUUiMr lo llw tltrl <unJi'd di vlitlon on r-^ch side ol Ihe nirta. Fo* IkoK
Kidtis InkIt Ord lo ciplnring the ••■ndltd dt vllllon. p\tm^ rhcck ■ lUllllta
Irtltatok and ^ludy Ihe aira omtrt 1 anntiat l.rtt eotvc.

TaMai.

rRKiRMI^IKi.AI

. HANA^:l.M^^f^ tK fAiiri*

sanil IIV.STT.BtCTJMV

BY a<:eat

IIVSir.RHTXlhtV ANnsr-VEPITV INDEX

S<?vert

I^ss Scvett

Hystetrcicwt^y Age

llvneteciimv Aie

UririiO

30 .^ over

Jlpdetjp ?0,ft9^.ef

(N-")

.78)

(H.

.18)

(N - 52)

L A

L S

tiseof

llormogsl t>tuct

I)»ni7nl and

0(^bc4h

t4 51 «

26.9

444

IR 34«

t>cna7oi

(l)in(icrtnc) ■

tnty

« 22 2

inj

27.7

S 9.«

Otal ronlracT

rpllvea

only
Uied neither

7 2J»

34 t

l«T

19 MS

n nn

2«2

III

in 19.2

X'-2n575;df..<»;p

. <on2

{continued on next page)

F.ndnintlrliMh Atunrlntliin

Oulcnmr i>r Stiiplrnl Inlmriiilun xKh ll^ilrrrcl'iiny

Only IS of IRO MYSfpaliciit^ f»ili<l lo rrf;|«>nd lo tlic qurj-
tlim: DiJ siirgny iitfcf rnllrfoi ciiic nfy.iui rnIl»lncllio^i^7 An

• nuly^lt 'h'lwcd lh»l pf |S1 c«^r<, 5(i.?% icp'irtrd siirRriy (m)
offered a It lief of c urr of rndoiiic Irion is; l^.l%"didn'l Vpnw
yet" or IhpiiphI It *«< loo t«ily In IcH." Tor tfxiul onc-lhiid
(M).6%), hvJlrrrrldiiiy offered Bcilhn relief nnr erne,

Deeiuse llic passage of lime sim c hysleieilnniy i\ «n Impor-
Unl v«ri«Mc In qucilinns of jyniploni rciurtcnce, infoinwlion
w««sougtil trilling to when suigny wis performed. Dull »eie
ivtIUIile fnf most c»5cs ind missing dati o< tuned rtndomly.
Estrogen lepUrenienl Ihriupy may tfTecl symploin lecorrcnee.
No simlsllcil differences between use of E.RT unit lliiir. since
hystcreclomy emerged (X' » 7.27; d.f. = 4; p = 0 IZ). In short,
Ihc decision to use IZRT wis not nffcrted hy lime since the
hyslerectoiiiy ind the decision lo use estrogen seemed lobe
mnde ibout the time of the surgery.

TaMi«. RTROGrNRETiACFMnNrnttRArr HvriMK

SINCE itvsn.nrx.-TDMv

r«lroten Benlacerrcnl ThenpY
Yes No TnUl

5 S i
Time since hviterectomt

Ih'sjeir IIJ JJl 13 1

One year ago 38 7 SO 0 40 3

Two years ago 17 3 (113)' 16 5

Ihreetlirnugli 4 years ago 18 7 15.4 |8 2

Five through 8 years ago 14 0 ~- 119

Total 150 28 |7(

X'- 7 27; d.f .4;p.NS*'
•Parenlheats Indicalea lesi than 5 palienli fell Inio Ihia calegory.

• • NS - pr ohahilily "p" is nol atalisltcalty signincanl.

Responses to Ihc question: "Did surgrry offer relief or cure of
your endnmelrlosis?" Mere coiiiparalile belwen the KR T and
NO HR r p.ilients. Perhaps Ihe most striking result (see Table 3)
was Ihal only about 2 of every J cases (6.^.2 to Ml%) believed
hysterectomy offered substantial relief or cure; 34.8% of Ihe
ERT group expressed a negative outcome; an almost Identical
percentage (33..ire) nf Ihe NO ERTs did so. Neither analysis
was altllstically slgnincanl.

TahW 1. niD StmCF.RV OfTTH RCt.tW OB CVKT. OF YOUH

wnroMcrmosis? oirrroMFDV r.nTSMnis

T>\i yurgerv Offer Relief or Cure?

fslrngeq

Hl'rotcn

ReplaecrpenI

Repf'cemfot

T1)<;r:ipi

UsUJiii

Yts No Tola!

Yes No Toul

S * »

» JL S

Time slne^hvslerectomv

Less than 2 yars ago

54 7 47 5 52 2

84 3 714 M7

Two years nf more

45 3 52 5 471

35 7 (28«)* 33 3

Total

75 40 IIJ

14 7 21

ferecnl of lolal

852 348 1000

887 33 3 1000

•Tarentheses Indicate less

than 5 p.sllenla. X' - 2.140; d f. • 3; p - NS

Reiau.^e Ihe gmiip without TRT was small, and the analyses
excluded patients Ulieving "It was to soon lo Icll" If surgery
would offer relief, an addilionat esamlnsllon was eonducled.
The "best case scenario" would occur If all cases in Ihe "loo
early" category fell into the column reflecting Ihal hyslerrctomy
did, In far I, offer relief or cure.

Once again, for ERT patients, surgery m-ide no slalistlcat
differemc In oulcaine; .10.5% still repirted that surgery offered
no relief or cure. Simultaneously, for those nol undergoing Ihe

Enrlomelrlnsli Assoelnllnn

palliative affects of eslmpen, surgery still did m't offer core for
2f>.''';5i IPalliative means treatment designed lo relieve or
rcduie Intensity of uncomfortable symplontt hoi not produce *
cure. I

Eslnigen Peplneement Therapy

The final two analyses are nol without methodological prob-
lems. At Ihe time Ihe que^linnnaire was constricted only
patients ici:eiving ERf were invited lo reply lo Ihe question:
if you had a hyslerectoniy and received r slrngen replacemeni,
did your endometriosis symptoms rci ur7 Tliis question waa
nol asked of palient5 not treated with ERT. Data in Table fi
describe symploai recurrence fm Ihe ERT group alone on 152
of Ihe 161 cases for whom data on all variables were available.
Results demonstrated that aytiiptoni.s of endonielriosia
reoccontd for 44.1% (X' - 34.39; d.f. - 8; p « <0.00l).

T»M« t BBCIIRJlEf CF, OF ENTK)MFTRIOSIS SVMTTDUB BV

TIir.llMESINCE IIVSrEPECTOMV
(N.I51 CA.'5FS WITH ERT ONLY) AND TTFB or
ERT VOUffnXERfD BV M CASES

Svmptoip Recurrence
Yea No Too early Total

to tell

& S S » L
Time since hrsiereciomT

Tlrisjear (4 5)* 8 9 27 5 118(11)

One year ago 25 4 42 2 57 5 38 8(59)

Two years ago - 23 9 15 8 (7 5)' 17 1(28)

Three through 4 yean ago 28 9 17 8 (5 0)* 18 4(28)

Five through 8 yean ago 19 4 15 8 (2 5) 13 8(21)

Total 87 45 40 152

Percent of total 44.1 29 8 28 3 ltX>.0

'Parentheses Indicates less than 4 patients tn these categories.
X' - 34 .39; d.f. . 8; p - <0 001

Typc of llorrrionat Replacemeni (N-g4>

Numher Perccnl of Total

Eatroten alone 28 40.8

«9 2(18)
19 2(5)

Symptoms fcinrncd

Symptoms did not relurn

looemlylnlctl I!. 5(3)

E^troecn wiih f;overt
Of DcPO rrovcft

Symplomi returned

57 1(18)

Symptoms did not relurn

17 9(S)

Ton early lo Icll

25 0( 7)'

Olhcr i»imblnalion|'

Symptoms relumed

100 0(9)

Total

«4

looo

45J

14.1

'Pfogtstrronc afonr (4 ct^M; endo recuncd); binli cf^lrol pills ilnne
(2 cjscs; endn rccuircd); estrogen, pcngcstcfonc, tnd birlh f cmtrd pilU
(I cJi«c; endo. rrcurrcd); progcxtrrone and birlh control plllt (I case;
cnJo. recurred); Mcgioe (I case; endo. recurred).
'Missing d:ti» - t

or 161 p»ticnU fccclvlnp ERT, 64 volunteered inrornutlon
ibout the kinds of estrogen received. With (he cavcul Ibut this
tiii^ll group noy nol be rrptc^cntnlrvc 0^x11 p^licnlft receiving
CRT. re^tilli :ihnwed 60.2% c xpericntcd n recurrence. If 3 cases
believing It v. is "ton curly lo tell" (if syiitptonu would rclvm)
■ ft excluded, Ihe percentage tncrcnscs lo 78 3%.

For Mimgcn, In combinnlion wllh Proven oi Depo-Proven,

llif ron>p»i»Me fvcitf nlJRc of p.ilirnls c jpcrirniinp, 5yniplnn«
»«« 57,1%; nmt iiuirr. cxi luJinp ^ n^c^ wlin tlid respond
l>c(iiu« It w«« "loo c»ily," Ihr pciirnlaRC risrs I" 76.2% — •
prircniagc rio.tc In Ihc r«lt foi r«li«grn »«d ilone.

I»I.S( tiSSION
Scvcr«l m rd* proinplrd Ihc rxaiiilnaliiin of Ihc prcvalrntr of
hystcrcttotny ttuonf* mcmWrt i^f thr slttjy ijfoup. firsl, Ihf
prrvalcnrc of hvslricitoiiiy, ilird m 19.5% iiminp, pillrnU of
«M igri pvri IS hy Ibr. National Crnlf i foi llcallh SlalMir.^,
Inditalc^ Ihal alioul I in 5 fcmalr.t will nndngo hyjlcrrtlnmy
duiing hf f lifrlltiie Im idrme lalr^ foi rndomcltlnsls. ranging
ftriii 17 lo 7A% of nr\» p.yncriilopii al palicnl< and surgical
idink^tons, Inctra^r llic risk of .<mgriy,' Ttic »ul«lanllal
prcvalcncr, and, perhaps, (br willingnc.^.^ lo Ircat f ndoniclnosla
wilh ?uigciy, niaiidairt an a.^^c.^'incnl of (loiv "good" hyslerec-
lomy, wllh and wilh"ul EBT, K »% an acifplcd thciapy.

Majoi Inlrtrst lies In Ihf qurtlion of whrlhct lolal atxlonilnal
hyulcfcclonty and Itilalc ral !talp[ngo-oopborccloitiy wllh ERT
lo offsci rnrnnpau^al .sympi'ints rau^cs a rrcuncnce of
endomcltlo'U. Convrtscly. dIH Ihr alj^cncr of fIRT facllllale
• cute o», al IrasI, a suhstanlial icdudlon In «)ntplom»7

Iff re, pcihajw wc taisc nK'it qurslloiu Ihan provide m^^m.
Re»oll.» showed lhal ahoul I In 10 p-ilient"; {^.0%) coniplrling
Ihe que.^lli'nnairt l>cl*crn I9R2 and I9R7 had a hyslereclomy,
i figuie IkIow Ihc n-illonal •vrrag'- for end«mrlri"Sis of 14.7'%
for all palicnis over )5 However, Ihe median ap,e for Ihe easel
examined here was .16 years. Tbe ptevalcnre of lolal ahtloml-
nat hy^leret lorny/l>lla!rral salpingo. opphorecloniy wat 7.1%;
n^.2% of Ihese Ifil easts received PRf,

Is Ihis rale atieplal'fc? Ceilainly, If lotil ahdonilpal hyslet-
etloniy/1>ilatf ral salpingo «»ophnrrcloniy Is acccpled as ihe
primary ii>oda1ily for c«re of rndoniclrio^ls, one would ques-
iiiin why patients wotiM eonlinur to see V additional approachei
for help. Although we found that ladiial suir;cry had been
used on paltrnis In llieir 2lls, the median and mean ages (3fi-37
yeart) Indiiatrd lhal prohaWy physicians were poj eager lo use
hystereelomy as a Irealriient alternative. The Severity Index,
unrclalcd to rrosl variaMcs, strongly dlffcrenlialcd patirnli In
Ihe IIYSTGR. Whether hysleiedoniv wasjuslinrd fir all
these patiepis remains unarwcred. Ilowever, we did find Ihe
majority of these pillcnis had disease Involving Ihe bladder
ind/otl>owels, and Ihey were older. That Ihe Severity lnde»
related l<» symptoms, perhaps, should lend greater credibility lo
patients' romplalnls nt gaslrolnle.slinal and bladder probleoLS.
Ilnwever, Ihe relatively short pe ri«'d of lime between di»gnosla
and hyslrrrrlomy, lo us. Indicated Ihr problem was due mnie
lo under-diagnosls rather Ihan a willingness for physicians lo
usr! hysterectomy as a Ireatnient for endometriosis, per se.

Among factors sopp/»rling Ihis contention was Ihe finding
lhal hysterectomy was used indiscrlmlnalely for married and
single women Agr and edui atlnn also were no respecter of
surp.ery. Rich or poor, educated or not, with the exception of
age (In thsl hystriei lomy patients as a Pf'T >" older),
hysterecti'my was an equal opporiunily technique.

We did Hrd lhal amonp. the IIVSTCR, less than half
(■IS 1%) had been treated wilh dana/ol (p <n.()i)l). Olven Ihe
widespread usngc of synlhetlr androgens (e.g., dana^ol), we
had In explore w by Ihis riwre const n'atlve approat h h.sd nol
Sen used more often, Why was Ihe attempt to midi^ ally
man.tge endorrtetilosls nol Irled for more than half of tlie sc
patients? Was Ihe condition of sui h severity lhal lolal hyster-
fitoiny was IndliaUd? (liven Ihe longrviiy of symptoms,
were Ihe patients simply tired of itlncs,s7 Are there remaining
"achools of thought" lhal polarise medical versus aargieal

therapy and ptri ludc Ihe use of less radical apptoar hen? In shoil.
It seems to W Ihr "older" wonirn (over 30) and Ihe lets severe
rases who have slipped throuph the system, Abusei In hyslertc-
loiny. If any, and as measured by hyttcrcclcniy of women in Ihett
2IK without previous treatment, were found In Ihe less severe
category: only 1 cases.

However. Ih> fad that only 2 of 3 (67.9%) were diagnosed and
treaird prior to hystciedoiMy was unripcited. The fad Ihil over
20%, al a minimum, were diagnosed siinullaneously at hyalerec-
loniy w'ts also sur^^rising One Is forced to ponder the lack of
early inl^fvention, both ntedically and aurgically, and Ihe use of
less drastic IreslmenI regimens.

Conclusions appear strong lhal II VST palicnis were moie
leriously ill, as measured on the majority of indlcalon of Illness-
leverity, and the Severity Index used here. Several naluni history
farlors werr sumniarired, Including Ihc grralrr prepondcrince
of dysmcnofthea and pelvic pain expcrieni ed throughout Ihe
menstrual cyi Ir, fatigue and low energy, dysparennla, nausea and
gnstric complaints anionr; several factorr atudled. Two iddillonal
faclors need eoiniiienl In a discussion of disease-severity. Tbeje
aupporl the conclusion thai palicnis nndergoing hysterectomy
were, siallstkally speaking, more III than their counterparts.

The pain prcnie and frequencies wllh which Ihe HYST GR
complained of severe pain — perhaps ■ nllonalc for surgery ralbei
Ihan prolopgc'l medical mana|^ement — Is one factor. Second,
disability data .showed greater Intctfcfcnee with daily lives ind
Incapacilallon for longer periods.

Does total hysterectomy, for ni.iny patients Ihe most dreaded of
procedures, cure end<imctriosls? Regretfully, as measured hert,
Ihe conclusion leached Is: No, nol always. According lo these
patients, 3.'' lo 35% rept'ri surgery offered neither relief nor cui«,
and 44.1% of those receiving ERT have eaperlencxd • return of
syiiiplonis.

A liniiled analysis of volunteered Information on estrogen
therapy showed nellher estrogen used alone, primarily as
Piemarin, nor estrogen in combination with progesterone, made
any difference In whether symptoms recuned. Progesleiont alone
was rarely used. Of four cases, ill experienced aymplom
recurrence.

Wr cannot answer whether lolal hysterectomy was used more
often Ihan warranted or whether palicnis were rushed lo hyslerec-
lomy before more ronsersalive medical measures were used Bui
■ccniding lo many patients' experiences we strongly suspecl that
Ihis procedure will neither relieve nor cure endoinetriosls. Perhaps
earlier diagnosis will liiipiove Ihis risk. Data on mediral tninage-
menl ol pallenis under 30 was encouraging,

Wfcrthrr the dodor and palleni decide against estrogen —aiti
decide lo sweat out mcmqiausal symptonis — for fear of
provoking return of endimietiiosls seems paradoxical. Estrogen,
or noeslmgrn. Tor many, rellbci made i difference. Sypifloms
continued to recur, irinfori ing lhal endometriosis remains inmng
Ihe niosl reshtani of diseases.

The search for etiological fat tors, as well as cures, remains
elusive. Cramer' suggests several avenues geared toward
prevention. The plausibility of other research, for example, Ifce
search for genetic"-' or < ongrnilal causes, and Ihe growing
possibility of underlying iinmunological disorders, such as
tep<irled by Dmowshl and his colleagues', niusi ronllnne lo be
supported.

This is an eapb'ralory study. Future research heps replication
and evaluation of Ihe serious qiiestlont raised here. Certainly, Ihe
poor rrsulls offrrrd by hysleredomy, wllh or without ERT, and
for nuny wt^nrn. the dis(omfi>r1 of Immediate surgital menopause
w ithnul rrspile, demands rigorous evaluation of IrealrrrenI
regimen* offered lo patients with endometriosis.

RF.FFRF.NCrF.^

I. Ilyilereelomlea In Ihe Opiled Slates. P«!-X4. Vital and Health

Ktallilia, US. OeparimenI of Health and Human Services, Public

Health Service, rrniers for niseate Control, National Center for Health

Sia'ljlles, ."Scries 13, No »2. IM7.

J. Arosla. AA, Butltam VC, feach PK. Malinak IJt, PranUln RR.

Vandertieyden HI A Pri^ised Clasilficatlon of Pelvic f^domelilosla.

Obslet CiynrenI 42 l<», 1973

J. Houston, Diana P; P.vidence for Ihr Risk of Pelvic rndomelriosla by

Aite, Race and Socioeconomic Status Fpldcm Rr» 6 167, 1984.

4 OamerDW. Cpidemlologjr of rndomeltiosla. In F.ndomtlriosh,

EA Wilson (Hd 1 Nr*, Vork:Alar R. I Jsj, Inc.. 19(17.

S. Simpson JL,nias),Matinak LR.nuIti ani VC Heritable Aspects

olEndonielrloala. I. Oenellc Sludlei. Am J Obslet Cyneeel 117:237,

I9R0.

(. Malinak IJI, nutirsm VC, Hllas S, Simpson )L Heritable Aspects

of Endometriosis. II. Olnlcjl Cbiraclrristics of ramillal

Cndomclrlo'la. Am J fibstrl Gynecol 1.17 332. I9B0.

7, Lamb K. Honminn RO, Nichola TK. Pamily Trail Analyala: A

Caae-Conljol Siudy of 43 Women with rndomelrlmla and TTieIr Heal

Ftlrnda Am J Obslel Gynreol 154:596, I9g«.

I. Dmowikl,WP.SlrcleRW, nakelCF tvlieleni Celluitt laamunlly

In Bndometrtnala. Am J Ohstel Cyiweol 141:377, 19(1.

Senator Mikulski. Thank you very much, Ms. Ballweg, for that
testimony. We know that the group that you represent is located
in Milwaukee and that it is an organization that provides much-
needed education and support for women with endometriosis, and
you have stated very well the case both for yourself and the need
for ongoing research.

Now, I'd like to turn to Ms. Mary Anne Marchase of Arnold, MD.
She was told by her doctor she needed a hysterectomy for fibroids,
but then sought alternative treatment.

And again, we thank you for sharing your personal story with us.

Ms. Marchase. Thank you. Senator Mikulski.

In July 1987, I married and moved to Arnold, MD from New Jer-
sey. A few months later, I had a medical problem. I felt a lump on
my left side, lower abdomen. Because I was new in the area, I
didn't have a doctor. A new friend who was pregnant at the time
gave me the name of her doctor. This doctor was well respected and
said to be very thorough.

On May 3, 1988, the doctor found that I had large fibroid uterine
tumors. She gave me the choice of a hysterectomy or a
myomectomy on my first visit. She advised that if I wanted chil-
dren, I should choose the myomectomy. In a myomectomy, the
fibroids are removed, but the uterus is left intact.

I got the impression it did not matter to her which option I
chose. I was shocked, because a hysterectomy is permanent and ir-
reversible. Even one of her office staff said to me, "I just had a hys-
terectomy, and I feel wonderful— just got back from a cruise." This
is major abdominal surgery in which an organ is being rernoved
from your body. She made it sound like she just got a new haircut.

The doctor scheduled a series of tests such as a pelvic sonogram
to check the size of the uterus and an intravenous pyelogram to see
if the enlarging fibroids were causing damage to my kidneys.

I left that office quite upset, but thought if I had the choice, why
would I choose the most radical one — the hysterectomy?

I went to the library and started to research my problem. I found
that fibroids were usually benign, they sometimes shrink by them-
selves, and no treatment is necessary. Many physicians recommend
hysterectomies as a treatment for fibroids in women who are past
childbearing age or who do not want any more children. Also, sur-
gery may be unnecessary, particularly for women nearing meno-
pause, when the decline in estrogen levels stop the fibroids from
growing.

I also read that you may be able to reduce large fibroids by elimi-
nating your intake of synthetic estrogen, present in oral contracep-
tives, estrogen replacement therapy, and red meat, since some cat-
tle are given hormones such as DES, and by reducing the intake
of animal fat.

I uncovered advances in laser surgery. There are several advan-
tages over conventional surgery. The laser penetrates to inacces-
sible parts of the body, it has pinpoint accuracy, and it seals the
blood vessels along their path. This results in less blood loss, swell-
ing, and trauma to the body. There is a lower risk of infection be-
cause the laser kills germs, speeds healing, minimizes the risk of
the complication, and shortens the convalescent time.

Meanwhile, my mother, who Hves in New Jersey, found out about
Dr. Goldfarb, who does laser surgery. We got more information
from his office.

I returned to the same Maryland doctor with the information I
now had and asked if I could go with the option of no treatment.
She advised me that because my fibroids were so large, they might
mask a more serious problem such as ovarian cancer, and she
wouldn't find it until it was too late.

When I questioned the Maryland doctor about laser surgery, she
was very closed-minded about it. I gave her copies of the articles
I read and a cassette tape of Dr. Goldfarb's lecture. She said the
people she respected didn't do laser surjgery, and a doctor that rec-
ommends laser surgery has to pay for his expensive equipment.

I knew now it was time for a second opinion, and I made an ap-
pointment with Dr. Goldfarb in New Jersey. He concurred that I
had a large cluster of fibroid tumors the size of a 14-week preg-
nancy. He stated that I did not need a hysterectomy, but I would
have to have a myomectomy.

I trusted Dr. Goldfarb and decided to have him perform the
myomectomy using the laser method. His philosophy is of the new
mentality in dealing with the problems of women. He believes in
being conservative and avoiding hysterectomies. He doesn't see
hysterectomy as the universal solution. He looks at each woman's
individual situation, since everyone's problem is unique.

Next, I arranged to store my own blood in the event it would be
needed since I lacked confidence in the blood supply. For my con-
valescence, I planned to stay with my parents in New Jersey.

I had the surgery on October 26, 1988. Dr. Goldfarb said it was
difficult, and another doctor might have opted for the hyster-
ectomy. There were approximately six different areas where
myomas, or tumors, existed, and approximately 12 myomas were
removed. It has been 4y2 years since my surgery, and I have had
no problems on my yearly checkups.

^fter returning to Maryland, I called the Maryland doctor and
told her my outcome. She said with surprise, **You mean you didn't
have to have a hysterectomy?"

There is a happy ending. This very same doctor was among the
first to learn the laser technology when it was recently offered at
her hospital. She is now using the laser to treat problems in gyne-
cology. I would like to think that I was a motivating factor in her
acceptance of this new procedure.

Before this, I was very healthy and had never been hospitalized.
I learned that you have to shop around for a doctor, and when
given the choice as to treatment, you must ask many questions and
do your own research. As Dr. Goldfarb says, doctors should do all
they can to maintain the integrity of women's bodies.

Senator Mikulski. Thank you very much, Ms. Marchase.

Now I'd like to turn to Greta Eley, who lives in this geographic
area. Ms. Eley recently had a hysterectomy for fibroids that re-
turned afler you had had a myomectomy, and you raised the story
that seems to be emerging about African American women. So we
look forward to your testimony.

Ms. Eley. Thank you. Senator.

There are several issues that I'd like to discuss regarding my ex-
perience with hysterectomy and the reproductive health care sys-
tem.

Prior to 1988, for many years, I had experienced painful men-
strual cramping and heavy bleeding. Despite ongoing visits to my
physician, I was given very little support and was told essentially
that, beyond pain mediation, there was little that could be done for
my problem.

In 1988, I scheduled a wellness assessment with my health in-
surer. Upon examination by a nurse, I was told that I had fibroid
tumors that were rather large, and that they were probably respon-
sible for a lot of my discomfort.

When I scheduled a follow-up appointment with my gynecologist
to check the fibroids, she told me she knew that I had them al-
ready and ihat "lots of black women have fibroids." She did not ex-
plain whj had fibroids, what causes them, or why black women
are at increased risk for having them.

My gynecologist recommended that I have a hysterectomy since
it was thought that I was already unable to bear children as a re-
sult of two previous surgeries. Since none of my doctors was certain
that I was infertile, I insisted that I get a second opinion from a
fertility specialist. I felt that if I had not insisted on having the op-
portunity of getting a second opinion, I would have been scheduled
to have the hysterectomy right away.

After examination and testing by a fertility specialist, I was
scheduled for a myomectomy to remove the fibroids. After the
myomectomy, the specialist came into my hospital room to examine
me and, without preliminary discussion, informed me that he had
been unable to repair my reproductive system and that my only op-
tion to have children was in vitro fertilization. Then, he left the
room without giving me a chance to respond.

Several years after the myomectomy, I continued to have painful
cramping and heavy bleeding, and a sonogram found that I had an
ovarian cyst. After hormonal treatments did not shrink the cyst, I
had a hysterectomy. This was 3 years after the myomectomy in
1991. I was 37 years old at the time. Was told after the hyster-
ectomy that the fibroids had also returned, but this was not told
to me before the surgery.

I felt that the insensitivity of both my gynecologist and the infer-
tility specialist was unnecessarily callous; however, nurses pro-
vided information and emotional support on both occasions. They
were wonderful advocates.

I am extremely concerned about the way women are treated by
the health care system. Unfortunately, in my conversations with
other black women, I do not find my experience to be unique.
Women are expected to accept what they are told by their physi-
cians, who often adopt a "need to know" attitude — they decide what
a female patient does and does not need to know about her repro-
ductive health.

There was never a discussion about how I felt about the prospect
of being infertile, nor was any discussion made about seeking emo-
tional support fVom either the mental health system or through a
support group of women like myself, even though I found out about
these services on my own, because they do exist.

I am angry at the messages women are often given by society,
that a doctor's decisions are sacred, and that one is not to question
or challenge their decisions. Until we change that message, women
are at risk of receiving reproductive health care that may not be
in their best interests.

I am a fairly assertive woman, but the difficulties that I experi-
enced would be rather hard to bear for women who, through lack
of access to health care or information about their bodies and
rights as consumers, could be stymied by the attitudes and behav-
iors of physicians who do not feel the need to be more supportive
of their patients as individuals rather than cases.

I was fortunate, however. I was able, through the support of
friends and from the education I received from nurses, to empower
myself to ask the right questions about hysterectomy and my re-
productive health options, and to demand to know the range of
services available to me. But who acts as an advocate for women
who are less fortunate?

Thank you.

Senator Mikulski. Thank you very much, Ms. Eley. Your testi-
mony, and all of the testimony, was very much appreciated.

I am going to ask some generic questions and, rather than call-
ing upon each one of you with an individual question, feel free to
jump in.

My first question is in terms of what was the impact of these
medical situations on you and your family; and then, what was the
impact on your health insurance, and how did that affect your fam-
ily?

Ms. Eley, did you want to speak on that?

Ms. Eley. Well, when I was told by the infertility specialist that
my only option was in vitro fertilization, he might as well have told
me that I would never have a child naturally, because my insur-
ance company does not cover that procedure; the cost is so prohibi-
tive that I would never be able to aff'ord to have something like
that done.

Also, the time involved — the time off work and possibly the pros-
pect of having to stay in bed for part of the pregnancy, when there
is no guarantee that you will become pregnant — was of concern to
me as well.

I feel that my health plan wanted to do what was cheapest, and
again, as I said earlier, had I not insisted upon getting a second
opinion, I would have had the hysterectomy 3 years before I actu-
ally had one.

Senator MiKULSKl. Did the others wish to comment?

Ms. Ballweg. Yes. As far as personal effects, for me, the effects
were much more devastating than I had anticipated. And I have
a wonderful support system through the Endometriosis Association.
Our headquarters is in Milwaukee, but we have groups all across
the continent and in fact around the world. It created a lot of prob-
lems in our marriage — and my husband is a wonderful man, but
I think it was very hard to come to terms with the devastating loss
of sex drive, to suddenly feel like a very old person when you are
actually very young. The changes are very personal and very hard
to come to terms with.

As far as insurance and the impact on our family related to hav-
ing a hysterectomy, it was quite amazing. Before I had a hyster-
ectomy I could not leave my insurance plan because no one else
would insure me. In fact, I tried to leave our HMO because at that
time, I knew that the six surgeons in that plan were not the best
for what I had to deal with. After the hysterectomy, I became very
insurable and have had no problems and have been told by our in-
surance agent that

Senator MncuLSKi. You are now more insurable than before?

Ms. Ballweg. Yes, because I don't have the female organs that
apparently they view as troublesome or more likely to lead to more
surgery.

Senator Mikulski. Troublesome organs?

Ms. BALLWEG. Right. So it has been quite an amazing experience.

Senator Mikulski. So in your case, your insurance costs went
down?

Ms. Ballweg. No. I don't think insurance costs ever go down. I
have not experienced that

Senator Mikulski. They will be by this time next year.

Ms. Ballweg. I hope so. But I actually had the flexibility to
change plans which I did not have when I had endometriosis.

Senator Mikulski. So freedom of choice was a very important
issue for you.

Ms. Ballweg. Freedom of choice is extremely important for
women with endometriosis. There are very few excellent surgeons
for endometriosis — perhaps only 50 to 100 across the country — and
these experts say that surgery for tough endometriosis is harder
than cancer surgery. If you cannot go to one of these people,^ you
might as well not have the surgery. For most women, that isn't an
option; they are in so much pain they must have something. So
many of the surgeries being done for endometriosis are not really
being done by people who are very, very skilled at it, and basically
are wasted surgeries.

Senator Mikulski. One of the things we are going to come back
to is what the medical profession says, because we are working on
the assumption that everybody wants to do the right thing, and I
think that people don't enter the field of medicine without wanting
to do the right thing. But something has kind of gone askew here,
and there are many other dynamics which we'll get to.

But you found that your medical condition took a great deal of
toll on your marriage.

Ms. Ballweg. Yes. Endometriosis is still taking a great toll in
our lives. Endometriosis is actually most likely an immunological
condition, and there are many related health problems — —
Senator Mikulski. Say what that means in plain English.
Ms. Ballweg. I'm sorry. The immune system is that system in
our body which tells our body when to launch an attack against
foreign invaders or against tissue that is not self Endometriosis is
tissue that is self, found in abnormal locations. For some reason,
in women with endometriosis, the immvme system is not function-
ing correctly; it does not know how to respond appropriately to that
misplaced tissue, and in fact, the reaction of the immune system
probably is the major part of the problem.

Senator MncULSKl. And this is also why you are raising some of
the issues around environment.

Ms. Ballweg. Absolutely.

Senator MlKUl^Kl. And one of the things we'll be talking to Dr.
Pinn about, our very capable and talented head of the Office of
Women's Health at NIH, is that there seems to be a pattern of
many women's conditions now emerging where there seem to be en-
vironmental linkages, and we'll be coming back to that.

Did anybody else want to talk about tne impact that this situa-
tion has had on their marriage or their primary relationship, and
also, then, what that did mean to your insurance, what options you
had?

Ms. Marchase.

Ms. Marchase. In my case, because I was new to the area and
did not have a support system, I was doing this research by myself
I just upset myself because of the doctor's nonchalant attitude.
That upset me. My husband said I was difficult to live with.

But as for the insurance, the cost of the operation

Senator Mikulski. In other words, your medical condition cre-
ated tensions within the family.

Ms. Marchase. Yes, it did.

Senator Mikulski. And what made you difficult, or caused you
to have those pricklv feelings that obviously it generated?

Ms. Marchase. I did not have trust in that doctor, and I was
upset and wanted to find a solution to my problem; but yet, I didn't
have trust in her, and until I found another doctor with whom I
felt confident

Senator Mikulski. So you were fairly obsessed with this.

Ms. Marchase. Oh, yes, I was.

Senator Mikulski. And in addition to the condition that you
faced, you felt that you were out there on your own.

Ms. Marchase. I felt that.

Senator Mikulski. Did you feel that you should call a medical so-
ciety, or — when you said you started to research on your own,
that's a pretty hefty undertaking.

Ms. Marchase. I did not know what else to do, and I felt I had
to do something.

Senator Mikulski. So you went to the public library?

Ms. Marchase. Yes.

Senator Mikulski. Had you thought about calling, say, the local
medical society?

Ms. Marchase. I didn't do that, no.

Senator Mikulski. So you went right to the library, where most
people go.

Ms. Marchase. Yes. I just wanted to get information about it so
that I would be armed the next time I went to the doctor, and I
would know what questions to ask.

Senator Mikulski. And then, once you embarked upon your pro-
gram with Dr. Goldfarb in New Jersey — and we are glad for the
happy ending which goes to your doctor in Ann Arundel County in
Maryland, that obviously, sne wanted to do the right thing and
then learned from you

Ms. Marchase. I am guessing that she learned fi-om me, but at
the time, she was very closed about the procedure. My objection is

that she should have said, "That is available; that is an option;
that is an alternative — ^but we don't do it here. You could try a
more progressive hospital." But she didn't say that; she was just
very negative about it.

Senator Mikulski. Now, what about your insurgmce company?
Were they negative about you going up to New Jersey?

Ms. Marchase. Not at all, no. The total cost of the myomectomy
was $5,000, which I think compares to a hysterectomy, and they
paid close to $4,300 on that. So it wasn't that it wasn't covered.

Senator Mikulski. Well, now that you've had your laser surgery
and so on, what is your family life like?

Ms. Marchase. Oh, much better. I'm very relaxed. Once that
was over with, it is a wonderful feeling.

Senator Mikulski. Because your medical problem was solved,
but also, you felt that you had found the answer.

Ms. Marchase. Yes.

Senator Mikulski. Ms. Eley, did you want to comment on any of
this?

Ms. Eley. I come from a very close-knit family, and the prospect
of not ever having a child was devastating to me.

Senator Mikulski. Have you had a child yet?

Ms. Eley. No; I have no children — although adoption is an op-
tion. At that time, though, I was not amenable to considering that
option.

Over the years that I went back and forth to the doctor, I was
made to feel as if I were neurotic, that I had psychosomatic symp-
toms. I felt a great deal of relief to understand that there was a
biological reason for the way that I felt the way that I did. I find
it inexcusable that my doctor knew this and never informed me.

Again, there needs to be a support system for women who have
these problems. I had to go out and find one. I did not get a refer-
ral from my insurer. As a matter of fact, I am a self-helper with
the National Black Women's Health Project, and working with
women who were supportive of not just this problem, but all health
problems that women, in particular black women, have was very
nelpful in my getting past my negative feelings about not being
able to have children. It is difficult.

Senator Mikulski. It is very difficult, very difficult.

You said that the nurses were really helpful to you. Could you
elaborate on what they told you that so empowered you, because
I think some of these aspects really go to health education and in-
formation, but health education that is empowering, that does not
reinforce stereotypes.

Could you tell us, because part of what we'll be looking at, even
in our efforts to reform the health insurance system — let me tell
you why I am asking some of these questions, not only in terms
of improving the situation with regard to hysterectomy, but obvi-
ously, for health care as a whole. Wnat is occurring is, if I can sum-
marize what you are saying, that many women access the medical
system through their ob-gyn. And for many of us, our ob-gyn is our
primary care physician and therefore could become the medical
manager.

The second thin^, though, in addition to ob-gyn services, even
where everything is appropriate, there needs to be support and

other information about all of the ramifications, what you are going
to go through. Even where a hysterectomy is appropriate, done
under the best circumstances, and nobody is worried to death about
insurance, it is a major— all surgery is a major impact. So you need
advice and so on, and that as well as perhaps even your husband
or your primary partner to also be able to call somebody and have
a cup of coffee or a walk around the block to understand that as
well, because not only are you being educated, but you need to edu-
cate your partner al>out what you are going through. That is a big
task, isn't it? So I wonder what role the nurses play— because we
are going to look at a variety of modalities for both doing actual
medical services and the education that goes into it.

Ms. Eley. When the nurse who examined me told me that I had
fibroids, she told me what they were; she told me what to expect;
she encouraged me to set up the follow-up appointment with my
doctor. In every instance where I had interactions with the medical
office, the nurses were in the forefront; they were able to respond
to my concerns, to empathize, and to provide emotional support.
When the infertility specialist told me that I could not have chil-
dren and walked out of the room, it was a nurse who came in and
held me in her arms as I cried.

I saw the doctors as technicians and the nurses as being very
nurturing individuals who could understand my feelings and give
me information in plain English that I could understand.

Senator Mikulski. Well, thank you. That was very, very moving.
You might find it interesting to know that I helped to pass legis-
lation so mat low-income women who are uninsured have access to
pap smears and mammograms, and one of the issues was to re-
move the barriers, of which we knew cost was only one. Now, we
have launched a program in Baltimore the other day, which will go
on in 30 cities, working with the YWCA, with a project called "En-
core Plus," to really help women overcome the fear of haying early
detection and screening. As thev go through the screening, there
will be a support group there for them, and then if the news is
cloudy or sad, they will not be left alone; there will be health care
providers, people really trained in public health, as well as working
with traditionally-oriented support groups.

Is this the kind of model that we are talking about here, where
you can get the best information, and then you have somebody who
sticks with you all the way through the process, if you want to
choose that?

Ms. Ballweg. I think that sounds like a beautiful model, and it
is very much what we try to do in the Endometriosis Association,
because women with endometriosis and girls with endometriosis
are deahng with a chronic disease that is going to have impact on
their lives over at least 30 years, generally. So we try to build in
a network of support at every level, from before they are diagnosed
until they are hopefully beyond the disease. I think your model
sounds beautiful.

Senator Mikulski. Well, going back to Ms. Eley, what she found
most helpful was the nurse, and then also her work with the Na-
tional Health Project of Black Women— is that the official title, Ms.
Eley?
Ms. Eley. The National Black Women's Health Project.

Senator Mikulski. Thank you. I'm sorry. I had all my words
mixed up. But still, you had that triad, then. So really, it would
seem to me, then, from lessons learned would be the need where
the physician knows the latest protocols and is wilHng to follow
those practice protocols, and also there needs to be information,
whether from the physician or someone connected with the physi-
cian, that then provides you with help; and that also, anything that
happens to women doesn't happen in a vacuum, because it affects
the primary partner and other members of the family — ^kids and so
on — I mean, if you were having all those prickly feelings, Ms.
Marchase, it would impact on the total family — and that also, free-
dom of choice is crucial, and then so are support services.

Are there any other ideas that you think we ought to be pursu-
ing? Ms. Ballweg, you spoke about the need for research. Is there
anything else you think we should consider as we now move to the
practitioners and researchers in the field?

Ms. Ballweg, I read about 35 medical journals a month, and
they are all oriented to physicians. One of the things that I see —
as you said, everyone works to the best of your ability, but there
has been a movement in modern medicine to make it more busi-
nesslike, time-motion studies, how many patients can you see in a
day, how to set up your support staff so that the doctor is in and
out of that room before the patient can even grab his coattails. I
think perhaps we need a movement back to a little bit more human
touch.

My father-in-law was a rural doctor; his patients sometimes paid
him in chickens, and he had a personal relationships that lasts to
this day as a retired physician. I think that the stories that I have
heard here reinforce the hundreds of thousands of stories I have
heard, which are that if the doctors would put themselves in our
shoes a little bit more often, they would be willing to take a little
bit more time with women, and that means a rethinking of what
it means to be a physician, but the rewards would be greatest for
the doctors themselves.

I think the polls show that most doctors today are pretty dissat-
isfied with medicine and looking forward to the future with great
fear. I think that if they reoriented their thinking back to why they
went to medical school and set up their practices with those ^oals
in mind, they too would find something really exciting in medicine
again, and it would help women tremendously.

Senator Mikulski. I also think we need to play a role in helping
doctors to practice hassle-free medicine. Ms. Eley, you spoke so elo-
quently about the nurses, but right now, whether it is at Mercy
Hospital in Baltimore, or over at George Washington Hospital, a
nurse will in the course of today fill out 19 forms, of which only
three are related to patient care, and the other 16 will be insurance
forms. Every one of the doctors who is seeing you has to face the
fact that 1,700 diflferent insurance companies in the United States
of America all have different forms. Forty percent of their overhead
goes to staff to deal with paper work and not public health edu-
cation, as well as the malpractice.

So I think the personal relationship I happen to enjoy with my
physician is absolutely crucial, but I think we have to make sure
that physicians can function in an environment where those things

that public policy can control reduce the hassle in being the doc
and let them get back to being docs.

Ms. Marchase, did you or Ms. Eley want to add anything else?

Ms. Marchase. I just want to say that I did the research, but
I think not everyone does, and that's what is unfortunate, that you
really do have to shop around for a doctor.

I have a friend who was told she needed a hysterectomy at the
age of 39, and she was willing just to do what her doctor said. She
had been with this doctor for years. Because her insurance com-
pany needed a second opinion, she went to another doctor, who
said, "You don't need a hysterectomy." Less than a year later, she
had a baby, and she had been married 12 years with no children,
and she is just so thrilled to have been blessed with this beautiful,
happy, healthy baby. And if she had listened to the first doctor, she
would have had the hysterectomy.

Ms. Eley. I'd like to comment on your model. I think it is a won-
derful one. I think that if we can provide women with information
in the supermarkets, in places where they go about doing the
things that women do, either in offices or as homemakers — I be-
lieve that education is power, and the more women who are edu-
cated, the more powerful they will be and the more they will be
able to make intelligent decisions about health care and not rely
necessarily on what the expert said.

Senator MiKULSKl. Thank you, Ms. Eley, and when Dr. Pinn
comes before us, we are going to raise those questions about Afiri-
can American women seeming to be more at risk. I think that is
so, and we would also like to be able to pass on to you the informa-
tion about what the YWCA will be doing, because I think it lends
itself to your work with your national organization.

We thsmk each and every one of you for your compelling testi-
mony. We know it is not easy to tell these stories, and we appre-
ciate your telling them, and we invite you to stay as we now pro-
ceed in our hearing.

Our next panel will provide a national overview of
hysterectomies and tell us the current State of knowledge about
the conditions that lead to hysterectomies, guidelines for them, and
alternatives to them.

We welcome the physicians who are here, and we know that each
and every one of you has done pioneering work in your own field
and are both scholars in the field as well as clinical practitioners.
We look forward to learning from you and hopefully, we can lower
the statistics regarding unnecessary hysterectomies and advance
our knowledge.

We would like to turn first to Dr. Vivian Pinn, who is the direc-
tor of the Office of Research on Women's Health at the National
Institutes of Health. Before she took on the responsibility at NIH,
Dr. Pinn was a faculty member at Howard Medical School, a distin-
guished scholar in her own right, and has been playing an out-
standing role in raising the consciousness of women around public
health as well as those in the research field.

Dr. Pinn, we look forward to hearing your testimony and once
again visiting with you.

STATEMENTS OF DR. VIVIAN W. FINN, DIRECTOR, OFFICE OF
RESEARCH ON WOMEN'S HEALTH, NATIONAL INSTITUTES
OF HEALTH, BETHESDA, MD; DR. VERONICA RAVNIKAR, UNI-
VERSITY OF MASSACHUSETTS MEDICAL CENTER, BOSTON,
MA; AND DR GEORGE W. MORLEY, DEPARTMENT OF OB-
STETRICS AND GYNECOLOGY, UNIVERSITY OF MICHIGAN
MEDICAL CENTER, ANN ARBOR, MI

Dr. PiNN. Thank you very much, Senator Mikulski. I am pleased
to have the opportunity to come before you to discuss some of the
issues related to hysterectomies, and I'd like to point out that I
have with me today in the audience Dr. Dwayne Alexander, who
is director of the Institute of Child Health and Development, and
also Dr. Gene Cohen, who is director of the Institute on Aging.

Senator Mikulski. Welcome.

Dr. PiNN. I'd like to start by saying, before I talk about the per-
spectives from the standpoint of NIH, that I certainly share your
strong concern and your timely initiative to better define the facts
related to hysterectomy.

As a member of the medical profession, but also as a woman and
also as a minority woman, I have both professionally and person-
ally experienced the challenges of decisionmaking in relationship to
pelvic pain, in relationship to myomectomy, in relationship to
endometriosis and uterine myomas, as well as having experienced
within my own family a lack of knowledge about natural meno-
pause and its natural progression, because almost every woman of
my parents' generation had undergone hysterectomy.

Senator Mikulski. Dr. Pinn, I am going to take this whole 30-
page statement of yours and put it into the record, along with the
footnotes. So feel free, then, to summarize what obviously will be
a very comprehensive statement.

Dr. PiNN. OK I'm not going to give you 30 pages' worth, believe
me.

Senator Mikulski. Well, you are worth 30 pages, so you go right
ahead.

Dr. Pinn. According to the National Center for Health Statistics,
in 1991, 555,000 hysterectomies were performed, and the highest
rate was for women between the ages of 45 and 64. Information on
minority women is sparse, largely historical and anecdotal. One
survey of women in Pittsburgh, for example, aged 40 to 42, found
a prevalence of hysterectomy of 23.7 percent in whites, but 46.9
percent in blacks. However, in the behavioral risk factor surveil-
lance study, a 16-State study of women over age 18, higher hyster-
ectomy rates were shown for women with less education and lower
incomes, but no independent differences between blacks and
whites. So obviously, we need to look at this data.

According to the National Center for Health Statistics' data, of
the almost 2 million hysterectomies performed during the years
1985 to 1987, the leading diagnoses were for fibroids,
endometriosis, uterine prolapse, cancer, endometrial hyperplasia,
and other conditions such as chronic pelvic pain, PID or pelvic in-
flammatory disease, and obstetrical complications.

There are, of course, risks associated with hysterectomy, related
both to nonfatal complications such as fever, infection, loss of blood,

and pulmonary embolism, as well as to a far lesser extent, surgical

mortality.

A number of long-term effects of hysterectomy have been de-
scribed, but of particular importance are the long-term effects re-
lated to the removal of the ovaries, such as osteoporosis and in-
creased cardiovascular diseases.

NIH has been increasingly involved in supporting research and
related activities on diseases and disorders for which
hysterectomies are being done and on developing alternatives for
hysterectomy, £md I'd like to just mention a few of those.

The National Institute on Aging in collaboration with the Wom-
en's Health OflRce will soon issue Request for Applications calling
for research on the natural history of the menopause, the impor-
tant point being that we hope in this Request for Applications to
be able to address the postmenopausal ovary and knowledge to
help resolve the debate on oophorectomy in association with hyster-
ectomy.

A recent conference on menopause sponsored by the National In-
stitute on Aging and the Women's Health Office and the National
Center for Nursing Research has helped to formulate recommenda-
tions for future research strategies, including an initiative to ex-
plore the impact of age-related changes in the female reproductive
tract that can lead to nysterectomies in midlife.

The National Institute on Child Health and Development held
two workshops in 1992, the second of which was cospon sored by
our office. These workshops were on conditions that can lead to
hysterectomy. Subsequentfy, the NICHD and our office jointly is-
sued a Request for Applications on endometriosis and fibroids,
which resulted in the award of six new research grants in Septem-
ber of 1992. And I am pleased to say that shortly after coming into
my position at NIH, recognizing even then, a year ago, the impor-
tance of learning more about the common conditions of fibroids and
endometriosis, that the major expenditure from our office was di-
rected toward these conditions.

NICHD currently has many other ongoing projects related to
endometriosis, as well as to fibroids, including looking at a study
of RU-486 as a possible therapy and also looking at the use of
gonadotropin-releasing hormone analog in the treatment of
myomas.

I'd like to indicate that the National Center for Nursing Research
will soon issue Request for Applications studying issues associated
with hysterectomy in premenopausal women, to include decision-
making, transitional care, and the long-term implications of the op-
eration. And in conjunction with the testimony of the previous wit-
ness, I can point out that in fact there is a study being conducted
by the National Center for Nursing Research >yhich is addressing
nursing care and their role in preparing the patient and the transi-
tion into pre, during and postsurgery related to uterine disease in-
cluding hysterectomy.

And of course, there are other initiatives, looking at some of the
other diseases that have been pointed out, or conditions related to
not only leading to the need for hysterectomy, but also resulting
from hysterectomy, such as the need for postmenopausal or, in this
case, surgically-induced menopausal hormone replacement therapy.

We know that there are many areas in which we still need re-
search to address not only alternatives to hysterectomy, but looking
at the need for the development of new medical therapies. We need
to look at the effectiveness of conservative surgery with respect to
both relief of symptoms and likelihood of repeat or more extensive
surgery. For benign diseases such as endometriosis, myoma, and
pelvic p£iin, there is a need for longer-term trials of medical treat-
ments, especially protocols which use lower doses and, ultimately
or in combination, include steroid replacement to prevent bone den-
sity loss and adverse lipid changes.

While we have some knowledge about medical and surgical treat-
ment for benign ^necologic disease, we have little information
about less conventional interventions. We do not know if there are
functions other than estrogen production of the endometrial tissue
or the ovaries that would continue to be important in
postmenopausal health. The safety of hormone replacement ther-
apy needs to be tested in women with a history of ovarian cancer,
and for women for whom hysterectomy is unavoidable, more infor-
mation is needed on the long-term biomedical as well as behavioral
consequences of hysterectomy alone, with removal of the ovaries
and with or without hormone replacement therapy.

There may be differences in the long-term consequences of hys-
terectomy for members of different racial, ethnic and socioeconomic
groups. Research is needed on the extent to which the diseases and
conditions leading to hysterectomy are preventable.

The NIH is committed to expanding its efforts on this significant
public health issue. We are strengthening our activities to expand
the knowledge base that will lead either to the prevention of those
conditions that today frequently result in hysterectomy or the de-
velopment of an array of improved alternative therapies for these
disorders.

We are grateful to you for the opportunity to address this critical
women's health issue, and I shall be pleased to answer any ques-
tions which you might have.

Senator MncULSKl. Thank you very much, Dr. Pinn, for that com-
prehensive testimony.

[The prepared statement of Dr. Pinn follows:]

Prepared Statement of Vivian W. Pinn

Senator Mikulski, and members of the Subcommittee on Aging, I am Dr. Vivian
W. Pinn, Director of the Office of Research on Women's Health, at the National In-
stitutes of Health (NIH). Thank you for the opportunity to come before you today
to discuss issues related to hysterectomies. As Director of the NIH oflice that is re-
sponsible for the coordination of all activities involving women's health, I km very
appreciative of the attention and outstanding leadership which you have continued
to provide for women's health research. I commend your interest in exploring the
conditions and diseases which may result in the removal of a woman's uterus and
ovaries, especially for benign conditions or in the premenopausal woman, and for
taking the initiative to better define the facts related to hysterectomy, the second
most frequently performed major surgical procedure in the United States.

The NIH recognizes the clinical and personal issues facing the women and their
families who must make difTicult decisions when the need for hysterectomies arises.
We recognize further the need to better understand the conditions and diseases
which are treated by hysterectomy, the consequent effects of hysterectomy with or
without removal of the ovaries, the potential psychosocial and familial impact re-
sulting from this type of surpcal procedure, especially in the premenopausal
woman, and the need for additional research to develop alternative therapies and
nonsuiigical interventions.

HYSTERECTOMY IN THE UNITED STATES

According to the National Center for Health Statistics (NCHS), the number of
hysterectomies performed in the United States peaked in 1975 at 740,000, and has
declined since then (1). In 1991, 555,000 hysterectomies were performed (2). Of
these, 8,000 cases occurred in Federal hospitals (3). ^

The overall rate of hysterectomy for all women over the age of 15 was 5.4 per
1,000 in 1991 (1). The data contained in Table 1 could not be analyzed by meno-
pausal status, but are presented by age. In 1991, the highest rate of hysterectomy
was for women between the ages of 45 and 64 (calculated from data m reference
2).

Table 1: Hysterectomy Rates Per 1,000 Women in 1991

A(e

Hysterectomy
Rates

15-44

6.0

45-64

7.5

Over 65

3.1

The last year for which hysterectomies were categorized by whether or not the
ovaries were removed at the same time (bilateral salpingo-oophorectomy) was 1987.
In that year, the overall percent of hysterectomy witn removal of both ovaries was
45.5 percent; without removal of ovaries, 54.5 percent (3). Table 2 shows the change
with age.

Table 2: Percent of Hysterectomies With Removal of Both Ovaries by Age, in

1987

Ate

Percent with
Removal of
Both Ovaries

20-29

24.2

30-39

27.7

40-49

57.6

50 and over

61.6

Information on minority women is sparse, largely historical, and anecdotal. There
are, however, some recent data. One survey oi women in Pittsburgh, ages 40-52,
found a prevalence of hysterectomy of 23.7 percent in whites but 46.9 percent in
Blacks (4). In the Behavioral Risk Factor Surveillance Survey, a 16-State survey of
women over age 18, higher hysterectomy rates were shown for women with less edu-
cation and lower incomes, but no independent differences between Blacks and
Whites (5).

REASONS FOR HYSTERECTOMIES

the NCHS has

In tabulating the number of specific diagnoses for hysterectomy,
used 3-year intervals, the latest of which is 1985-87. In Table 3 these data are ex-
pressed as percentages of the total by indication for each age group. Overall, of
1,967,000 hysterectomies during that period, 10 percent were for cancer, 6 percent
for endometrial hyperplasia (excessive growth of the uterine lining), 30 percent for
myoma (also known as fibroids), 19 percent for endometriosis (uterine lining cells
growing in abnormal locations), 16 percent for uterine prolapse (loss of support for
me pelvic organs), and 19 percent for other conditions such as chronic pelvic pain,
pelvic inflammatory disease, and obstetrical complications (6).

^Federal hoepitals include thoee of the four armed services. Veteran's hospitals, and Indian
Health Service hospitals. These 8,000 cases are not included in the subsequent data used in this
statement

Table 3: The Indication for Hysterectomy by Age (Percent) in 1985-87

Age C«ncsr Hyperphsi* Myoma Endometriosis Pro?ame ^^^

15-44 6 3 30 24 12 24

45-55 6 10 45 15 14 10

55+ 31 11 12 3 33 10

The more frequent indication for hysterectomy changes dramatically with age. For
women under 55 years of age, endometriosis and myoma are the most common
causes of hysterectomy, while for women 55 and over, cancer and uterine prolapse
predominate (6).

RISKS ASSOCIATED WITH HYSTERECTOMY

Death rates immediately after hysterectomy vary considerably. In the absence of
cancer or pregnancy, rates range from 6 to 11 deaths per 10,000. For obstetrical in-
dications, the reported rates are 28 to 39 per 10,000; for cancer patients, reported
surgical mortality rates relating to hysterectomy range from 70 to 200 per 10,000;
and, for benign diseases they are estimated to total about 300 deaths annually in
the United States (7).

In a series of studies, the incidence of nonfatal complications of hysterectomy
ranged from 25 to 50 percent of cases. The most common complication is fever (15-
32 percent) from a respiratory, urinary, or wound infection, or an unknown source.
Other complications include hemorrhage requiring transfusion (8-15 p>ercent), injury
to adjacent organs (0.5—1.4 percent) and pulmonaryembolism (blood clot to the
lungs, 0.2-0.3 percent). In all categories, vaginal hysterectomy, which does not re-
quire an incision in the abdomen, was less risky than abdominal (reviewed in ref-
erence 7).

A number of long-term effects of hysterectomy have been described, but not well
documented. There is a significant need for more data in this area, particularly with
respect to any racial and ethnic differences. The long-term effects may include pre-
mature ovarian failure, persistent pelvic pain, constipation, urinary symptoms, fa-
tigue, depression, and diminished sexual interest and response (7). From the few
psychiatric studies on this topic, it appears that the emotional response to hyster-
ectomy relates to the woman's presurgical personality traits, strength of her support
system, and family history. Studies also suggest that patients at greatest risk of de-
pression after hysterectomy are women under 35, those who have not had children,
those who desire future children, and those who experienced a postoperative faU in
ovarian steroids.

Of particular importance are the long-term effects related to removal of the ova-
ries, rather than the uterus itself. These are the loss of bone which leads to
osteoporosis, and a pattern of serum lipids (cholesterol and triglycerides) associated
with increased cardiovascular disease risk. These changes are associated with the
loss of estrogen due to the removal of both ovaries. Estrogen replacement therapy
is effective in ameliorating the bone changes and reversing the lipid changes seen
after removal of both ovaries (8).

Recent studies have indicated that prevention of ovarian cancer alone is not a suf-
ficient justification for removal of the ovaries at the time when hysterectomy is per-
formed for other reasons. The lifetime risk of death from ovarian cancer for a 50-
year-old women is 0.8 percent (7). The patient's age, menopausal status, and will-
ingness to adhere to a hormone replacement therapy regimen should also be
weired in the decision. Most discussions of the benefits to the cardiovascular and
bone systems of hormone replacement therapy assume that the patient will take the
medication perfectly. In reality, medicine-taking behavior in general is less than
ideal. Leaving the ovaries in has to be weighed against "preventively" taking them
out when followed by hormone replacement taken the way people really take medi-
cines. When this is taken into account, keeping the ovaries in results in longer cal-
culated survival (9).

ALTERNATIVES TO HYSTERECTOMY

Benign Disease. Expectant management, or watchful waiting, is indicated and ap-
propriate when symptoms of benign disease are not distressing to the patient and
the uterus is not enlarged. In premenopausal women, conditions such as
endometriosis and myoma usually stabilize or regress at the time of natural meno-
pause.

Furthermore, recent advances in technology have enabled us to follow more close-
ly the status of many conditions which may lead to hysterectomy. New ways of
forming an image of the internal organs without X-rays, such as ultrasound with
a vaginal probe, and more recently, magnetic resonance imaging (MRI), are ex-
tremely accurate and reproducible for measuring and following the size of the uter-
us, the size of myomas, and thickness of the endometrium (uterine lining).

When the effects of benign disease become more symptomatic, the usual first line
of treatment consists of medical therapies and conservative surgical approaches (7).
Since endometriosis and myoma generally require the female hormone estrogen for
growth, medical treatments have centered on medications which interfere with the
effects of estrogen. These include progestins (which resemble the ovarian hormone,
progesterone), danazol (an anti-hormone), and more recently, analogs of
gonadotropin releasing hormone (GnRH) (a brain hormone involved in reproduction).
Abnormal uterine bleeding may also be treated with steroids or danazol, or with
nonsteroidal anti-inflammatory agents similar to aspirin (7).

Some patients, however, cannot tolerate the side effects of steroids or danazol.
GnRH analogs and antiprogestins, a new class of hormone blocker, are promising,
but have onfy been usea in short term trials so far. GnRH analogs, in particular,
have produced an overall reduction in myoma size and uterine size of 40-50 percent,
but the effects last only as long as therapy is continued. The low-estrogen State pro-
duced by GnRH analogs, however, limits their usefulness because it can lead to de-
creased bone density. Therefore, these drugs are most useful, for brief periods, as
a preparation for surgery, or if the patient is expected to enter menopause shortly

(7).

Conventional treatment of chronic pelvic pain consists of oral contraceptives or
nonsteroidal anti-inflammatory drugs. This condition, however, responds even more
readily when a multi disciplinary strategy is undertaken, including medical, behav-
ioral, and other approaches.

There are simple approaches to nuld or moderate uterine prolapse. These include
placement of a pessary (an internal device to support the uterus mechanically) and
exercises to strengthen the pelvic muscles. Major surgery is usually indicated for se-
vere prolapse.

In the past, total hysterectomy for benign disease has been justified on several
grounds, mcluding; 1) prevention of future ovarian cancer (by removal of the ova-
ries), 2) the fear and nsk of missing a hidden mali^ancy, 3) pressure on adjacent
organs, 4) increased surpcal risk if this operation is postponed until a later time,
5) compromised fertility if conservative surgery is attempted, or 6) risk of worsening
the benign disease by postmenopausal hormone replacement therapy.

There is, however, no convincing evidence that hysterectomy conveys a benefit be-
cause of these reasons, and, as discussed earlier, the risks are not negligible (10,11).
For example, historically, physicians have considered major surgery necessary when
the patient has a mass in the pelvis, because of the fear that the uterus or ovaries
might be harboring an undetected malignancy. However, high-resolution ultrasound
now allows the exact location and other characteristics of such a mass to be identi-
fied, and allows its size and character to be carefully followed. Uterine masses in
premenopausal women are overwhelmingly benign. Therefore the decision on man-
agement can often be made based on the woman's status, presence of bleeding or
other symptoms, and information over time from modem imaging techniques
(10,11). , . .

Now, conservative surgical approaches which spare the uterus are growmg m use.
Benign abnormal uterine bleeding that does not respond to drug therapy can often
be controlled by dilatation and curettage. An increasing number of practitioners are
using endometrial ablation, the removd or scarring of the endometrium, to treat in-
tolerable abnormal bleeding. Simple removal of myomas, or myomectomy, either
through an incision or using a hysteroscope, can be highly effective, and has a low
compfication rate. Repeat myomectomy or hysterectomy is required in less than 20
percent of cases (7).

New approaches, including vaginal hysterectomy with laparoscopic assistance, and
hysterectomy through a laparoscopic incision, have not been thoroughly evaluated
in terms of outcome. In the past, hysterectomies performed for benign conditions
and for cancer could not be jjerformed vaginally. Large fibroids, for example, may
have made a uterus too large to remove through the vagina. Adhesions from
endometriosis or pelvic inflammatory disease may make hysterectomy unsafe except
from the traditional abdominal approach. Exploration of the pelvis and upper abdo-
men recommended for patients with cancer could not be performed througn the va-
gina.

Approaches that use hormone replacement therapy to shrink fibroids before sur-
gery, including laparoscopic surgery, have made vaginal hysterectomy a realistic op-

tion for many more women than in the past. For prolapse, surgeir to lilt and sup-
port the pelvic organs usually suffices unless the degree of prolapse is extreme.
Endometriosis is usually treated by local removal of lesions when medical manage-
ment fails or produces undesirable side effects (7). , . _ .

In obstetrical complications such as severe hemorrhage, uncontrollable infection,
and inversion of the uterus, measures which spare the uterus may be tried if the
patient desires future fertility. As a last resort, hysterectomy is done when these
fail and there is a potentially life-threatening emergency (7).

Malignant Disease, for malignant disease, the choice of management varies with
the type and stage of the cancer. Early, localized cervical cancer usually may be
managed with conservative surgery, such as removal of part of the cervix, that
leaves the body of the uterus intact. Intermediate stages of cervical cancer can be
treated with radiotherapy or hysterectomy. Advanced cervical cancer is treated with

radiotherapy. , , . , , c 4.^^

Hysterectomy is the accepted treatment for endometrial cancer and cancer ot the
uterine muscle (leiomyosarcoma). On occasion, hormonal agents may be tried in
young women with low-grade endometrial cancer who wish to preserve fertility.
Hysterectomy with removal of both ovaries is generally performed for all stages of
ovarian cancer. When cancer is confined to one ovarv in a young woman desiring
future fertility, removal of one ovary is an option which may be considered.

In summary, modem techniques for noninvasive monitoring of benign disease, as
well as availability of medical and conservative surgical treatments, have contrib-
uted to the decline in hysterectomy rates. Physicians are developing greater con-
fidence that treatment which spares the uterus can be safe for the patient. New de-
velopments and wider access to these techniques and treatments will continue to
make alternative strategies even more reliable and attractive.

MH-SUPPORTED ACTIVrnES RELATING TO CONDITIONS WHICH CAN LEAD TO
HYSTERECTOMY, AND TREATMENT ALTERNATIVES

NIH has been increasingly involved in supporting research and related activities
on diseases and disorders Tor which hysterectomies are being done, and on develop-
ing alternatives to hysterectomy. I would like to detail some of these initiatives and
studies being conducted or supported by various NEH components.

National Cancer Institute (NCI): Research by the NCI-funded Multi-institutional
Gynecologic Oncology Group is examining the safety of estrogen replacement ther-
apy in women with endometrial cancer who have been treated with hysterectomy
and removal of both ovaries. Retrospective data suggests that estrogen replacement
may be safe for these women. This summer, NCI's Clinical Oncology Pro-am will
expand the Surgery Branch to include a new gynecologic section evaluatmg treat-
ment of gynecological malignancies.

National Institute on Aging (NIA): The NIA is stimulating an expanded research
focus on the menopause and the role of age-related changes in the female reproduc-
tive tract in the development of gynecologic disorders. A major research conference
on menopause recently sponsored by NIA in coniunction with ORWH and NCNR
helped formulate recommendations for future NIA, research strategies. Topics cov-
ered a wide range of biomedical and behavioral areas, including ovarian biology, car-
diovascular health, changes in bone, and genitourinary function, and the impact of
this life event on minority women. TTie discussion included, for example, ongoing re-
search on effects of hormone replacement therapy on urinary incontinence, an im-
portant concern for women undergoing either surgical or natural menopause.

NIA will soon issue a Request lor Applications (RFA) in collaboration with ORWH
calling for a comprehensive, multidisciplinary research effort on the natural history
of the menopause and the role of the perimenopausal transition on women's aging
and subsequent susceptibility to disease. The initial phase of this effort will estab-
lish cohorts of premenopausal women, and will include minority women to redress
the previous neglect of determining ethnic differences in menopause research. The
research effort will also focus on the postmenopausal ovary and the dynamics of hor-
mone replacement therapy and therapeutic alternatives, contributing important
knowledge to the debate on oophorectomy.

NIA has already begun a perimenopausal study of African-American and Cauca-
sian women in its intramural researcn program, as part of the Baltimore Longitu-
dinal Study of Aging. NIA is also planning a major initiative to explore the impact
of age-related changes in the female hysterectomies in midlife. This solicitation
seeks new strategies to reduce the burden and the high rate of hysterectomy stem-
ming from disorders or conditions such as myoma and aberrant gonadotrophin and/
or ovarian hormone dynamics as women progress from pre- to postreproductive sta-
tus.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Lon^tudinal, prospective clinical studies funded by NIAMS are investigating the
specific dose and formulation of estrogen that is most effective in estrogen-deucient
women and the assessment technologies necessary to follow carefully the clinical
course of bone health in these women who may be at increased risk of fracture. Sev-
eral studies are directed to the measurement of bone quality and quantity using
dual energy X-ray absorptiometry, computed tomography, magnetic resonance and
ultrasounoT In addition, biochemical markers of bone remodeling, found in blood and
urine, may in the fiiture prove to be extremely useful in the assessment of treat-
ment effectiveness as well as in the prediction of risk. The development of
biomarkers for osteoporosis was the subject of a Workshop held by NIAMS in De-
cember 1991 and will be a major thrust in the NIAMS BONES (Basic Osteoporosis
New Experimental Strategies) Initiative to be launched in 1993 and implemented
in 1994.

National Institute of Child Health and Human Development (ICHD) Two work-
shops were held in 1992 on conditions which can result in hysterectomy —
endometriosis, abnormal uterine bleeding, and myoma. The NICHD and ORWH co-
sponsored the second workshop. An explicit empnasis of these workshops was the
desire of NTH to stimulate research leading to new diagnostic and therapeutic ad-
vances that would reduce the number of hysterectomies done for these conditions.

The NICHD and ORWH, with guidance from the workshop participants, and in
response to a direction from the 102nd Congress, jointly issued a request for

applications on endometriosis and myoma, which resulted in the award of six new
research grants in September, 1992.

In addition, the NICHD currently supports four ongoing clinical projects on
endometriosis. The four ongoing grants include two projects on the interactions be-
tween endometriosis amd immune cells, and two involving antibodies against
endometriosis or proteins made by endometriosis cells that could be used as diag-
nostic markers. One grant in each of these two areas was co-funded by ORWH.

Some other projects have been the research of three groups working with animal
models of endometriosis, and an animal study of postsui^gical adhesions (scarring),
a common complication of hysterectomy. Recent clinical investigations have included
a preliminary study of antiprogestin therapy for myomas, and a study of prevention
of bone loss by ovarian hormones in women with myomas treated with GnRH ana-

log.

Nl(

ICHD-supported research teUs us that the uterus has functions other than as
a site for fetal growth. Little is known about the impact of these functions elsewhere
in the body. Removal of the uterus may thus have unsuspected consequences beyond
loss of fertility. Therefore, it is important to know what the normal endocrine and
metabolic functions of the uterus are. Seven projects are addressing this area.

Three investigations are components of a large program project grant devoted to
the production, metabolism, and regulation of hormones in the uterus. Specifically,
they involve metabolism of steroid hormones, regulation of the receptor which allows
the uterus to respond to steroids, and regulation and production of another class of
hormone, the prostaglandins. Two grants support studies on interaction between
steroids and proteins known as growth factors in regulating the growth of
endometrial cells. One study looks at how prostaglandins act on their target tissues,
including mediating effects of estrogen on the uterus. A young physician scientist
is directing her investigations at a molecule involved in the immune response which
is especially abundant m endometriosis tissue.

Other projects currently underway include a novel drug delivery system that
could be used for GnRH analogs or other drugs used in benign disease such as
endometriosis or myoma; and a Small Business Innovative Research (SBIR) pilot
project on an instrument to quantify changes in uterine physiology in patients with
pelvic pain.

National Institute of Diabetes and Digestive and Kidney Diseases (NTDDK): The
NIDDK supports studies on irritable bowel syndrome (IBS), a very common bowel
disorder associated with abdominal pain and altered bowel habits. Approximately 67
percent of the people who have symptoms of IBS are women, and approximately 85

fiercent of those who seek treatment for this disorder are women. Women with IBS
requently consult gynecologists, and are three times as likely as women without
IBS to receive a hysterectomy. Hysterectomy usually does not relieve their pain,
and, may, as a side effect, predisposes the woman to urinary incontinence. Prelimi-
nary studies indicate that women have lower thresholds for pain due to distension
of the colon. Current research is evaluating some of the physiologic responses to co-
lonic disfention and the role of abdominal pain in reference to menses.

National Heart, Lung, and Blood Institute (NHLBI): The risk/benefit picture for
hormone replacement therapy is a critical issue for women facing a decision about

hysterectomy with or without removal of one or both ovaries. Several NM Insti-
tutes, led by NHLBI,^ support the Postmenopausal Estrogen/Progestin Intervention
(PEPI) Trial of hormone replacement therapy. The goal of this trial is to examine
the effects of various hormone replacement strategies on cardiovascular risk factors,
cancer, and osteoporosis.

Another NHLBI clinical investigation on cardiovascular risk factors includes a
study of effects of intensive dietary intervention levels of HDL and LDL cholesterol,
wei^t gain at the time of menopause, age at menopause, percent of women using
hormone replacement therapy, or having a hysterectomy.

Several ongoing observational studies are collecting information on the use of es-
trogen and estrogen plus progestin and their association with lipid levels, coagula-
tion factors, and clinical events (8).

National Institute for Environmental Health Sciences (NIEHS): NIEHS conducts
and supports research into environmental hazards that may be related to diseases
and conmtions that are often treated surgically by hysterectomy. NIEHS studies of
substances in the environment that are estrogens or that act biologically as
estrogens suggest that these substances may be casually related to cancers of the
uterus or utenne fibroids. Both of these health conditions may be treated by hyster-
ectomy. In addition, NIEHS studies of DES and its effect on the children of women
given this drug are also relevant.

The goal of this environmental health sciences research is to identify and prevent
the kinds of environmental exposures that lead to diseases and conditions of the fe-
male reproductive system and to prevent unnecessary surgical interventions.

National Institute of Mental Health (NIMH): NIMH has an extensive extramural
research program focusing on women's mental health across the reproductive cycle.
The intramural program of the NIMH has recently established a women's mental
health research center. Of particular interest is mood changes during the
perimenopausal period, and their relationship to biological changes. The dramatic
biological consequences of hysterectomy, and their potential effects on mood, are ob-
viously relevant and of great interest to these programs. In addition, NIMH has a
national education program on Depression Awareness, Recognition and Treatment,
that reaches women and the clinicians who treat them.

National Center for Nursing Research (NCNR): An organization that is poised and
ready to make a meaningful contribution to our knowledge about the behavioral as-
pects of hysterectomy is the National Center for Nursing Research, soon to be NIH's
newest institute. The nursing research community is well positioned to study such
issues as promoting more rapid healing and recovery following surgery; describing,
analyzing, and ameliorating postsurgical symptoms; studying symptom management
through such therapies as diet and exercise alone or in combination with hormone
replacement therapy; and helping women make informed decisions about elective
surgery andpostoperative therapy.

The NCNR is already quite active in this type of research. Scientific studies ad-
dress how to manage the well woman's typical symptoms during menopause, which
can also help promote understanding of what goes wrong when a woman's symp-
toms are abnormtd. The goals are to distinguidi and treat, or ameliorate, the nor-
mal or abnormal symptoms that occur during a woman's middle years. NCNR sup-
ported NIH's first Center for Women's Health Research, located in Seattle, Washing-
ton. That Center focuses on such typical mid-life symptoms as sleep disruption and
gastrointestinal disturbance, as well as how women respond to stress.

NCNR has recently funded a study on transitional care. The study involved re-
leasing women who had hysterectomies early from the hospital, and subsequently
provicfing them with home follow-up care from clinical nurse specialists. These
women evidenced improved health outcomes and expressed greater satisfaction with
their care. There was also a cost savings of 6 percent which, ^veu the number of
hysterectomies performed in this country, could be substantial if the study findings
were to be replicated nationwide.

The NCNR will soon issue a Request for Applications aimed at studying issues
associated with hysterectomy in premenopausal women. The request will include
studies concerning women's decision making, transitional care, postsurgical recov-
ery, symptom management, and the long-term implications of the operation.

National Center for Research Resources (NCRR): NCRR supports a nationwide
network of General Clinical Research Centers (GCRCs). These provide a clinical set-
ting in which investigators with other sources of research funding conduct their

"The NIH institutcB participating in the PEPI Trial include, in addition to NHLBI: National
Institute of child Health and Human Development; National Institute of Diabetes, Digestive,
and Kidney Disease; National Institute of Arthritis, Musculoskeletal, and Skin Diseases; and
National Institute on Aging.

studies. Current studies include a number of basic, clinical and epidemiologic inves-
tigations into diseases and disorders that lead to hysterectomy, including myoma,
endometriosis, and endometrial and cervical cancers. Examples of recent projects
under way in GCRCs include the following: Treatment of endometriosis and myoma
with antiprogestin; long-term treatment oT myoma with GnRH analog; treatment of
endometnosis with G^H analog delivered by nasal spray; recurrence rates for
myoma following myomectomy; outcome after endoscopic management of
endometriosis; and basic studies of the role of hormones in the development of
endometrial cancer. The NCRR also supports animal model research, including stud-
ies of myoma response to hormones and GnRH analogs in primates, and develop-
ment of a transgenic animal to study the link between papilloma virus infection and
cGi^ricftl C&J1C61*

Office of Research on Women's Health (ORWH): The Office coordinates the devel-
opment of an overall NIH women's health agenda and funds research studies
through other NIH components. Examples of such collaborative efforts range across
the biomedical research spectrum and include: an animal model testing trans-
formation of normal ovarian cells to cancerous cells (NCI); testing a model for the
hospital to home transition for women needing that special attention required by
a patient newly arrived at home (NCNR); a study in low-income African Anaerican
women examining their perceptions and knowledge of menopause, interest in hor-
mone replacement therapy, and health-seeking behaviors (NCNR); and a study of
reproductive failure as a result of endometriosis (NICHD). Of the 95 awards made
by ORWH in 1992, 19 (20 percent) related directly to the problems or issues faced
by women as a result of menopause including surgery.

The Women's Health Initiative (WHI): The largest women's health researdi effort
ever undertaken, the WHI is a prevention study to examine the major causes of
death, disability, and frailty — ^heart disease and stroke, cancers (particularly breast
and colorectal), and osteoporosis — in postmenopausal women (ages 50 through 79
years) of all races and socioeconomic strata. The study wiU ultimately involve about
160,000 women. It will examine, through clinical trials and observational studies,
the effect of a low-fat diet in preventing breast and colorectal cancer and heart dis-
ease; the benefits and risks of hormone replacement therapy in preventing cardio-
vascular disease and osteoporotic fractures; and the effects of calcium and vitamin
D supplements in preventing osteoporotic fractures and colorectal cancer. The WHI
will also study the effect of ERT on endometrial cancer.

About 30 percent of the women to be recruited into the clinical trial are expected
to have had an hysterectomy. Of particular interest are the benefits of estrogen re-
placement therapy in reducing the risks for cardiovascular diseases and osteoporosis
in these women. The randomized clinical trial will also examine psychosocial and
quality of life issues in women on hormone replacement therapy. For example, cog-
nitive functioning and various behavioral measures related to lifestyle events will
be studied with tne goal of assisting women to adopt healthful behaviors that will
reduce their risk of disease and maximize their health. These guidelines will also
enable health care professionals to assist and support their patients.

RESEARCH NEEDS ADDRESSING ALTERNATIVES TO HYSTERECTOMY

WhUe we have begun to explore the use of new medical therapies, much more
data are needed on tneir use alone, or in combination with surgery that spares the
uterus. Studies are also needed on the effectiveness of conservative surgery with re-
spect to both relief of symptoms and likelihood of repeat or more extensive surgery.

For benign disease such as endometriosis, myoma, and pelvic pain, there is a need
for longer-term trials (greater than 6 months duration) of medical treatnaents, espe-
cially protocols which use lower doses, and, alternatively or in combination, include
steroia replacement to prevent bone density loss and adverse lipid changes.

While we have some knowledge about medical and surgical treatment for benign
gynecologic disease, we have little information about less conventional interventions.
These modalities could be effective alone or enhance the utility of medical manage-
ment, especially for such conditions as chronic pelvic pain.

As the population of the United States continues to age, the impact of aging in
development of conditions leading to hysterectomy takes on added importance. ^e
do not know if there are functions other than estrogen production of the endometrial
tissue or the ovaries that continue to be important in postmenopausal health. For
example, it is not well understood whether removal of the postmenopausal ovary
plays a role in osteoporosis. Removal of the premenopausal ovary is known to be
a major factor in developing osteoporosis.

Research efforts might be directed at developing combinations of ovarian hor-
mones and other agents as a potential treatment for endometrial cancer. Younger

women with endometrial cancer may be treated effectively with these combined new
agents, with hysterectomy being reserved for those with persistent disease.

Because the risks of hormonal replacement therapy are unclear in patients with
a history of ovarian cancer, many clinicians do not prescribe it for these women. The
safety of replacement therapy needs to be tested in women with a history of ovarian
cancer or ovarian tumors of low malignant potential.

In women for whom hysterectomy is unavoidable, more information is needed on
the long-term biomedic j^ and behavioral consequences of hysterectomy alone, with
removal of the ovaries, and with or without hormone reolacement therapy. The safe-
ty of estrogen replacement therapy in women with a history of ovarian cancer or
ovarian tumors of low malignant potential still needs to be determined.

There may be differences in the long-term consequences of hysterectomy, with or
without removal of one or both ovaries, for members of different racial, ethnic, and
socioeconomic groups. These ^ould be sought as necessary guidance for manage-
ment decisions regarding treatment and foUowup.

Both the public and health care professionals need more information on what can
be done to minimize, eliminate, or manage the biomedical and behavioral con-
sequences of hysterectomy. A wide range of options must be pursued.

Researeh is needed on the extent to which the diseases and conditions leading to
hysterectomy are preventable. This would primarily include factors that influence
the development and growth of endometriosis, myomas, endometrial hyperplasia,
and gynecological cancer; and causes of pelvic relaxation.

STRATEGIES ADDRESSING THESE NEEDS

The National Institutes of Health has a portfolio of research on issues surround-
ing the prevention of hysterectomy as well as those interventions which preserve
quality of health and life should hysterectomy become necessary. Yet, further efforts
are clearly required.

The Office of Research on Women's Health (ORWH), the NIH office whose man-
date is to identify and foster a trans-NIH research agenda on women's health across
the life span of women, has defined areas for action in a recent report: The National
Institutes of Health: Opportunities for Research on women's Health (12). This docu-
ment, created from a 1991 public hearing and scientific workshop, delineates gaps
in knowledge in women's health in specific age categories and cross-cutting areas
of science. Recommendations for addressing biomedical and behavioral researeh is-
sues surrounding hysterectomy, particularly those which emanated from the work-
ing^groups on the ages of the life span, provide valuable guidance.

The ORWH Workshop Working Group on Young Adulthood to Perimenopausal
Years (15-44 years of age) recommended that researchers pursue several parallel
lines of inquiry. Those recommendations included:

What can be done to prevent hysterectomy, infertility, and early fetal loss if
a woman suffers from endometriosis or myomata?

How can fertility can be enhanced? How can the potential for childbearing be
preserved in pre-menopausal women with benign diseases which were fre-
quently treatea in the past by hysterectomy?

What are recommended treatments for women who suffer from chronic pelvic
pain?

What methods should be implemented during this life segment for preventing
lung, breast, colorectal, uterine, and ovarian cancers in later years?
The ORWH Workshop Working Group on Perimenopausal to Mature Years (45-
64 years of age) recommended additional studies on a variety of different research
issues. Such recommendations included:

What are the effects of hormone replacement therapy on heart disease;
breast, uterine, and other cancers; osteoporosis; and mental health?

What are the changes, both psychological and physiological, that occur in a
woman as she approaSies and enters into menopause?
What are the effects of early menopause on the health of a woman?
What are the psydiological and pnysiological effects on women as they age?

The ORWH Workshop Working Group on Mature Years (65 years and older) pro-
vided similar recommendations.

What are the long-term psychological and physiological effects of menopause?
What are the ways that health care workers can be made aware of the special
problems faced by women over age 65?

What measures can lead to an improvement in women's self-esteem during
this part of the life span?

Can the increased prevalence of depression among women having had an hys-
terectomy (either pre or post menopausal) be prevented or reversed?

With an estimated 35 percent of women in this country over the age of 60 having
had a hysterectomy, and a substantial number of younger women at risk for hyster-
ectomy, finding answers to these and related research questions, becomes critically
important.

As the focal point for action on women's health across the NIH, our goal is to
make women's health issues an integral part of scientific inquiry at NIH and
throughout the scientific community. Drawing together the different NIH initiatives
relating to hysterectomy has provided yet another important opportunity to examine
gaps in knowledge and to stimulate change to enhance women's health. Your inter-
est and support has encouraged us to redouble our efforts in this important area
of women's health.

CONCLUSIONS

While hysterectomy rates are declining, 35 percent of American women will have
had an hysterectomy by the time they reach the age of 60. Approximately 300
deaths per year occur after hysterectomy for benign disease. Some medical therapies
are available, but each has potential problems for many women. More information
is needed on nonsurgical interventions and other treatments. The risks and benefits
of surgery that spares the uterus also need further study.

The NIH is committed to focusing its efforts on this significant public health
issue. In particular, we are strengthening our activities to expand the knowledge
base that wiU lead to either the prevention of those conditions that today frequently
result in hysterectomy, or the development of an array of improved alternative
therapies for these disorders. NIH recognizes that prevention may be an important
key to avoiding unnecessary hysterectomies.

We are grateful to you. Senator Mikulski, for providing the impetus and leader-
ship to concentrate our attention even more intently on hysterectomy and alter-
natives to this procedure, and to spur us to increased collaborative efforts.

I shall be pleased to answer any questions you may have.

REFERENCES

1. National Center for Health Statistics, Pokras R, Hufnagel VG. Hysterectomies
in the United States, 1965-1984. Vital and Health Statistics. Series 13, No. 92.
DHHS Publication no. (PHS) 88-1753. Washington. US Government Printing Office
(1988).

2. Personal communication from Mr. Robert Pokras.

3. National Hospital Discharge Survey, National Center for Health Statistics,
CDC (unpublished data), 1991.

4. Meilahn EN, Matthews KA, Egeland G, Kelsy SF. (Characteristics of women
with hysterectomy. Maturitas 11:319-329 (1989).

5. I^erulff, K, Langenberg P, Guzinski, G. The Socioeconomic correlates of
hysterectomies in the United States. American Journal of Public Health 83:106-108
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6. Pokras, R. Hysterectomy: Past, Present, and Future. Statistical Bulletin, 70:12-
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7. Carlson KJ, Nichols DH, Schiff I. Indications for hysterectomy. New England
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8. Nabulsi, A, et al. Association of Hormone Replacement Therapy with Various
Cardiovascular Risk Factors in Postmenopausal Women. New England Journal of
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9. Speroff T, Dawson NV, Speroff L, Haber RJ A risk-benefit analysis of elective
bilateral oophorectomy: effect of changes in compliance with estrogen therapy on
outcome. American Journal of Obstetrics and Gynecology 164:165-74 (1991)

10. Friedman AJ, Haas ST. Should uterine size be an indication for surgical inter-
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12. National Institutes of Hetdth. Opportunities for Research on Women's Health.
Bethesda, Md: National Institutes of Health; 1992.

ADDITIONAL READINGS

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DeSimone D.P., Stevens J., Edwards J., Shary J., Gordon L. and Bell N.H, Influ-
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Gordon T., Kannel W.B., Hjortland M.C., and Mc Namara, P.M., Menopause and
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Senator Mikulski. We would now like to hear from Dr. Veronica
Ravnikar.

Dr. Ravnikar. Thank you, Senator Mikulski.

As a practicing obstetrician-gynecologist, I have been asked to
justify the use of hysterectomies to address the growing concern
that hysterectomy rates are high, while there is a paucity of re-
search on the conditions that lead to a hysterectomy and a lack of
studies on the long-term sequelae.

Although the first issue, the number of hysterectomies per-
formed, is the responsibility of peer review by ob-gyn, the latter
two are related to the use of past — and I underline in Dr. Vivian
Finn's presence and the presence of the current Democratic admin-
istration— past research support by the Federal Government on
women's health issues.

The removal of the uterus, known as hysterectomy, is a valid
surgical technique in the armamentarium of the ob-gyn. The ob-gyn
is a primary care provider of women throughout their lifetime.
Along with the appropriate emphasis on prevention of disease, with
careml patient education and screening techniques, a good example
of which is the use of the pap smear, an ob-gyn is uniquely quali-
fied to definitively cure certain anatomic ailments in women by ap-
propriate use of the procedure of hysterectomy. This in turn offers
improved quality of life and freedom from incapacitating pelvic
pain and bleeding and the fears of cancer.

Current newer techniques in ob-gyn surgery, examples of which
are laparoscopic hysterectomies, laser laparoscopic surgery for
endometriosis, and electrocautery of the uterine lining to stop ex-
cessive hemorrhage, offer more conservative approaches to hyster-

ectomy. However, these procedures have not been vaHdated com-
pletely in regard to their efficacy.

We do, however, need to critique the rates of hysterectomy, the
second most frequently performed surgical procedure in the United
States. Nevertheless, the number of hysterectomies peaked in the
mid-seventies and have stayed the same for a decade.

The median age for hysterectomy in females is 40.9 years. The
rates under 30 years are 10 percent; 30 to 50 years are 65 percent;
50 years or older, 25 percent.

Regional differences in the rates of hysterectomies also exist. The
Northeast has the lowest rates and the West the highest rates. In
the Northeast, the rate has been 4.1 per 1,000; in the West, 8.1.

In 1985, the Canadian National Health Care Plan reported a
rate of 5.9 percent 1,000 women, while in the United States, the
rate was 6.8 per 1,000 women. In England and Sweden, 17 percent
of women have had a hysterectomy by age 65, compared to 33 per-
cent in the United States. These rates indirectly indicate great var-
iability in the decisionmaking process and in the use of medical al-
ternatives.

There is therefore a great need to do comparison studies on the
effectiveness of medical versus surgical approaches to ailments that
lead to hysterectomy. Fibroids lead to 30 percent of all
hysterectomies. These are benign tumors, but they may lead to ill
health by causing bleeding, pain, pressure on other organs, and
miscarriages. There is medical treatment for such, namely, LHRH
agonist therapy, which is not as of yet approved by the FDA for use
in the treatment of fibroids. Even with an approval indication, for
example, in endometriosis, it is approved for only 6 months of use.

However, once the medical treatment is topped, the fibroids may
also recur. The cost-benefit factor and patient satisfaction with this
medical alternative need to be weighed against the definitive cure
produced by hysterectomy.

The objective criteria that many insurance companies use to de-
termine need of hysterectomy is not necessarily correct. Fibroids
comparable in size to a 12-week-sized pregnant uterus are consid-
ered appropriate for surgical therapy. Large fibroids, however, may
create no symptoms, whereas small fibroids, depending on their lo-
cation, can cause major symptoms with excessive bleeding.

One-third of all hysterectomies are also associated with bilateral
removal of the ovaries. Oophorectomies are usually performed in
the older individual, since it is felt that the ovaries are
nonfunctional postmenopausally, a fact that also needs further
study, and in the younger female, when the disease process war-
rants it, such as in endometriosis.

It is estimated that 700 prophylactic oophorectomies would be re-
quired to prevent one case of ovarian cancer. However, the occur-
rence of ovarian cancer is still frightening, since 60 to 70 percent
of cases have reached an advanced stage 3 prior to initial diag-
nosis. Ovarian cancer is responsible also for 52 percent of deaths
from gynecologic cancers. Prophylactic oophorectomies are sug-
gested in families of patients with a strong family history of ovar-
ian cancer.

Finally, 50 percent of all ovaries that are left behind after hyster-
ectomy need to be subsequently removed within 5 years, due to
pain, adhesions and cyst formation.

Chronic pelvic pain, either due to endometriosis or to no discern-
ible anatomic etiology, is another cause for hysterectomy. A large
number of chronic pelvic pain patients have a history of childhood
sexual abuse — in some reports, as high as 60 to 70 percent.

We must consider the psychologic makeup of our patients and
not only the anatomic. There is need for greater mental health care
reimbursements to facilitate assessment and follow-up of the men-
tal health status of our patients. Depression following hysterectomy
varies in incidence between 3 to 23 percent dependent on the study
population and preexisting depression. Sexual dysfunction rates are
also reported high, but these are again dependent on preexisting
conditions.

Peer review has been a significant factor in decreasing hyster-
ectomy rates. There are ongoing peer review studies which support
this fact — the North Carolina Appropriateness Study and the
Maine Study of Hysterectomy Outcomes.

My recommendation is to enhance peer review systems in the in-
dividual States. Remember, hysterectomy rates are high, but have
not increased in a decade. We need to develop controlled trials to
study alternative therapies to hysterectomy. Most hysterectomies
are done for benign conditions and in women in their early 40's,
the decade of transition into the menopause. Therefore, studies on
the normal processes of aging in ovary and uterus are imperative.

The final decision to proceed with a hysterectomy rests between
the patient and her physician. A total health care approach is
needed to address her physical and psychologic needs. Finally, we
need greater fUnding for research projects that deal with these
common but important health care concerns of women. In this way,
we will increase the alternatives, both medical and surgical, that
the practicing ob-gyn can use. It will be the most effective way of
decreasing the rate of hysterectomies.

Thank you.

Senator Mikulski. Thank you very much. Dr. Ravnikar. We
know that the background that you bring as the former director of
the Fertility and Menopause Unit at Mass General brings you a
great deal of background, and we understand you are also now
practicing at the University of Massachusetts Medical Center.

Dr. Ravnikar. That's correct.

Senator Mikulski. So you ran a fertility and menopause unit,
and are you doing research as well now. Doctor?

Dr. Ravnikar. Yes, more menopause clinical research.

Senator Mikulski. Thank you. We'll come back to those ques-
tions, because there seem to be some themes.

[The prepared statement of Dr. Ravnikar follows:]

Prepared Statement of Veronica Ravnikar

The growing concern among medical researchers and practitioners that hyster-
ectomy rates are excessive, especially for benign conditions and the lack of agree-
ment on the criteria for determining which hysterectomies are necessary.

Hysterectomy rates are quite high and hysterectomy is second only to caesarean
section as the most frequently performed major operation in the United States. Hys-
terectomy rates actually peaked in the mid 1970'8 and since then there has been

somewhat of a decline to a very stable albeit high rate. The rates of hysterectomy
are, therefore, very little changed from those of two decades ago. This translates to
1980 having an estimated rate of hysterectomies of 649,000 performed in the United
States. There are racial differences In 1978 the hysterectomy rate for black women
age 15 to 44 was 972 per 100,000 compared with 777 for white women. This may
reflect different genetic causes leading to hysterectomies such as increased incidence
of fibroid tumors.

The medium age for hysterectomy is 40.9 years. The rates under 30 years are 10
percent, 30 to 50 years are 65 percent, 50 years or older are 25 percent. Thirty per-
cent of hysterectomies are done for fibroids and are done between the ages of 35
to 55. Therefore most hysterectomies are done for benign indications. There is a 30
percent ofincidences of fibroids in women over 30 years of age.

There are also regional differences in hysterectomy rates. In 1987, for example,
the overall rate for hysterectomy in the United States was 6.6 per 1,000 women per
year. In the Northeast the rate was the lowest at 4.1 per 1,000, in the Mid-west
6.5 per 1,000 and in the West 8.1 per 1,000 and in the South 7.4 per 1,000. In Can-
ada, where there is a national hesuth plan, the rates are 5.9 per 1,000 women. The
1985 figures for the United States in comparison were 6.8 per 1,000 women. In Eng-
land and Sweden 17 percent of the women have had a hysterectomy by the age of
65. In the United States 33 percent of women have had a hysterectomy by the age
of 6.

Finally, there has been a consistency of the number of hysterectomies per year
from 1979 to 1987 ranging about 675,000 per year. This mav be due to the fact that
tubal ligation became a more in use as an accepted surgical procedure for steriliza-
tion after 1975 and also in part because of the peer review process leading to second
opinions prior to hysterectomies.

Uterine fibroids account for approximately 30 percent of hysterectomies. However,
the natural history of untreated fibroids has not been studied. Simply: Why do they
need to be removed if they are asymptomatic? It is known that fibroids are common
in women and especially in the black population and this may lead to the higher
rate of hysterectomies in the black population. There area no real criteria concern-
ing asymptomatic fibroids. Empirically it has been felt that 12 weeks gestational
sized uterus is too lai^e and may warrant removal because it may obscure the ova-
ries. The fear is that ovarian cancer could be missed. However, at times the uterus
with fibroids smaller than 12 weeks may create more problems and so justifying a
hysterectomy just on the basis of size may be irrational.

Fibroids can develop bleeding, leading to anemia, pelvic pain, pressure on other
organs. This may not be totally dependent on their size. The submucosal or fibroids
in the lining of the uterus are the ones that sometimes create the most problems
and yet the uterus may be pretty much normal size or slightly enlarged. Tnerefore,
substantiating the need for hysterectomy basically on size alone is not warranted,
although appears to be common practice.

The use oi drug therapy with GNRH agonist which decrease peripheral estrogen
production and tnerefore temporarily decrease the size of fibroids is an important
medical alternative. However, as soon as the agonists are stopped, fibroids grow
back to the original size, mainly due to the fact that peripheral estrogen levels are
restored. The growth factors needed for fibroid growth are therefore, present again.
There is further work in using GNRH agonist combined with hormone replacement
therapy as a long-term treatment, although this is also very costly. It suojects the
patient to daily use of hormones and pills. There is potential for recurrence of the
problem once these drugs are stopped. Finally the FDA has not approved LHRH
agonist therapy for fibroid use. Also, long-term sequelae of such therapy compared
with definitive treatment of fibroids via hysterectomy is unknown.

The other alternatives to a hysterectomy for fibroids are myomectomy (removal
of the fibroids alone), or excision of the fibroids through hysteroscopy. Even though
these are more conservative maneuvers that preserve the uterus, tney may subject
the patient to recurrence of the problem and requiring a secondary procedure.

The next recurrent problem that leads to hysterectomies 20 percent of the time
is called dysfunctional uterine bleeding which refers to regular noncyclic bleeding
that may at times lead to hemorrhage. This dysfunctional uterine bleeding may be
due mainly to an anovulatory State which is common in a woman over 40 as she
is transitioning to the menopause and/or due to the prolonged unantagonized estro-
gen effect on the uterine lining causing a hyperplasia (overgrowth of the lining).
Hysterectomy is necessary in patients who have hyperplasia with atypical changes
and endometrial cancer. These diagnoses may be made either by office sarnpling of
the endometrium, adilatation and curettage, or hysteroscopic evaluation. Patients
who have dysfunctional uterine bleeding can be managed in the perimenopausal pe-
riod with intermittent progestin therapy. Careful monitoring of any substantiated

hyperplasia is mandatory. A hysterectomy is not always necessary unless there is
fear of an indolent undetectable endometrial ctmcer or unless the dysfunctional uter-
ine bleeding affects the cpiality of life in the individual. An alternative that needs
studv is what is called endometrial ablation where an electric cattery technique is
used with a rollerball type of device that ablates the endometrium. This if very ef-
fective in abolishing and reducing bleeding in 70 to 90 percent of cases. Long-term
outcomes and recurrence rates are unknown. In about 25 percent of the cases oleed-
ing may recur. Nevertheless in the evaluation of dysfunctional uterine bleeding
thought must be given tomedical alternatives and to proper diagnosis before resort-
ingto hysterectomy.

The next main reason for hysterectomies is endometriosis and what's called
adenomyosis (endometriosis of the wall of the uterus). Endometriosis, even though
it comprises 1 out of 5 hysterectomies, also is associated with multiple invasive sur-
gical procedures in women who are in their 20'8 and 30's. Patients present with a
diagnosis of pelvic pain dysmenorrhea, dvspareunia, irregular bleeding and infertil-
ity. This disease category can be treated, with other investigational surgical proce-
dures (laparoscopy). Hysterectomy is usually resorted to for intractable pain relief
and/or after other conventional surgical procedures have not been benefiaal. There-
fore, analyzing the other surgical techniques for endometriosis (number of
laparoscopies) would be an important component in evaluating the value of hyster-
ectomy for endometriosis.

Since growth of endometriosis is directly related to sex hormones, hysterectomies
for endometriosis are associated with bilateral oophorectomies in order to cure the
patient of the condition. This may lead to further morbidity and mortality since
most of these patients may be younger in age and undergo the premature sequelae
of bone loss and heart disease if they are not estrogen supplemented at least until
age 50.

Patients with endometriosis therefore are very complex patient management prob-
lems. Major breakthroughs have been achieved with using GNRH agonist to allevi-
ate the symptoms and bleeding due to endometriosis. However, more work and more
research needs to be done so that the side effects of the GNRH agonist can be over-
come with estrogen feedback therapy. In the case of endometriosis the cost benefit
and quality at Ufe studies need to be done comparing repeat conservative
laparoscopic surgery vs long-term medical management (costly) vs definitive cure
with a hysterectomy.

The next major cause for hysterectomy is that of genital prolapse which comprises
of about 15 percent of hysterectomies. The indications for surgery of the genital
prolapse are varied. Part of the syndrome of genital prolapse include pelvic pres-
sure, loss of urine, rectal discomfort and ulceration of genital organs when they are
exteriorized. Little is known of the natural history of prolapse including the efficacy
of vaginal surgery for relief of these symptoms. Few studies have been done regard-
ing recurrence rates and need for recurrent surgery.

Conservative management includes using pessaries to lift the organs back into
their natural place and the use of topical estrogens and exercises to strengthen the
pelvic floor. The coincidental hysterectomy for the removal of the normal uterus
when the main symptom is urinary incompetence is not known to be of benefit, al-
though it is often done. Most genital prolapse occurs in the older age group in the
50's and 60's and these women may suffer more morbidity and mortality from elec-
tive hysterectomies than women who are in their 40's.

Ten percent of hysterectomies are due for chronic pelvic pain and these may be
of varied etiology mainly that due to fibroids, due to endometriosis and/or due to
uterine prolapse. Any patient having chronic pelvic pain without an exact anatomic
diagnosis needs an evaluation of her bowel, bladder, and musculoskeletal systems,
and psychosomatic reasons for pelvic pain. It is important to note that childhood
sexual abuse is associated in 40 to 60 percent of pelvic pain patients. Therefore, pa-
tients not having any known anatomic reasons for chronic pelvic pain would be
mandate to have a psychological evaluation prior to the surgery. Medical therapy
has been used for these conditions including the nonsteroidal anti inflammatory
agents, oral contraceptives and GRHN agonists, since may patients with dironic pel-
vic pain may start with this illness at a younger age, the long-term use of such hor-
mones is important to objectify. A comparison, therefore, needs to be made with the
immediacy and thoroughness of a symptom relief with hysterectomy with long-term
medical management in the third, fourth and fifth decade of a lifetime of an individ-
ual. Pelvic inflammatory disease is a very rare indication for hysterectomies and
this could be mainly associated with chronic pelvic pain due to the chronic adhesive
process that forms after art acute infection.

Endometrial hyperplasia accounts for approximately 5 percent of hysterectomies
and again it is important to document that the hyperplasia in such an individual

is associated with an element of atypia. Therefore, not all patients that have
endometrial hyperplasia need a hysterectomy. Medical management is a valued
technique in tnis regard and progestin therapy has been shown to reverse
hyperplasia and therefore this should be the primary modality of therapy initially.

The best example of newer modalities of treatment decreasing the hysterectomies
is in the diagnosis of cervical interrupt epithelial neoplasia, invasive uterine cancer
and other cancers. We know that conservative followup with PAP smears has done
much in decreasing the incidence of invasive uterine cancer; and also that most cer-
vical intra epithelial neoplasia class 1, 2 or 3 is best treated conservatively either
with laser, vaporization or excision, cone biopsy, loop surgical excision or
cryotherapy. In rare cases, hysterectomies are mandated for cervical intra epithelial
neoplasia class 3 that cannot be removed with conization. Hysterectomy is the defi-
nite treatment for early invasive cervical cancer. Hysterectomy is also the mainstay
for treatment of adeno carcinoma of the endometrium and also for uterine sarcomas
and mixed mesodermal tumors of the uterus. r v • v •

There are obstetrical indications for hysterectomy. The most frequent of which is
bleeding due to uterine atony. Emergency hysterectomy for uncontrollable hemor-
rhage in obstetrical situations actually carries the greatest morbidity.

Nlortality rates after hysterectomy range from 6 to 11 per 10,000, mainly for indi-
cations not involving obstetrical issues or cancer. Mortality rates are 29 to 38 per
10,000 when associated with an obstetrical outcome and 70 to 200 per 10,000 when
the indication is associated with cancer. Abdominal hysterectomies have almost a
1.7 time higher rate for complications than vaginal hysterectomies. The operative
stay for abdominal hysterectemies is also longer than for vaginal hysterectoniies.
Newer approaches to hysterectomies include the laparoscopic assisted vaginal
hysterectomies or hysterectomies performed through a laparoscopic incision. Even
though these are heralded as decreasing both the morbidity due to larger incisions
and decreasing the hospital stay for patients, long-term outcomes are unknown.
Complication rates appear to be lower. However, this may be directly related to the
skill of the surgeon The operative time of these procedures is also directly related
to the skill of the surgeons: it is longer than standard hysterectomies. Credentialing

Erocedures of surgeons and long-term evaluation of these alternatives to standard
ysterectomy is necessary. Needless to say, these alternatives are not going to de-
crease hysterectomy rates but rather decrease costs of hospital stays.

The effect of hysterectomy on urinary symptoms is unknown and it has been esti-
mated that bladder abnormalities may develop in 20 to 30 percent of patients who
have had hysterectomies, which is a profound statistic. Worsening of sexual function
has also been reported in 1 out of 5 cases.

In discussing the psychological morbidity with hysterectomies it is important to
note that some of the older statistics did not include whether or not a oophorectomy
or removal of the ovaries was removed with the hysterectomy. Terminology is impor-
tant in the fact that a total abdominal hysterectomy involves only the removal of
the uterus and cervix. A total abdominal hysterectomy and a BSO or bilateral
salpingo-oophorectomy refers to the removal of both ovaries. Bilateral salpingo-
oophorectomies are generally done in women over 40 because it is thou^t that this
would prevent ovarian cancer and also that the ovaries will no longer function after
age 50 and therefore may necessitate removal. The other reason to remove the ova-
ries are in women where their basic disease process is felt to be due to ovarian ster-
oid production. An example of this that has already been discussed is that of
endometriosis. Since endometriosis is in general considered to be menstrual lining
displaced in the peritoneal cavity of the patientl removing the uterus alone may not
cure the condition. Therefore, removing the ovaries and the source of hormones may
give more complete relief of symptoms if it is due directly to endometriosis. The
problem is that, in general, most of these hysterectomies will also be done in young-
er individuals since endometriosis peaks at age 20 to 35.

Another condition which at least in the past was thought of also to necessitate
a bilateral salpingo oophorectomy was in patients with pelvic and inflammatory dis-
ease. We now know tiiat this is not necessary for thorough relief of symptoms and
in fact lysis of pelvic acDiesions for PID and also laser cautep^ of endometriosis is
an alternative procedure for symptoms relating to these conditions.

Long-term study outcomes comparing conservative measures against total abdom-
inal hysterectomy are really unknown.

The advantages of an elective oophorectomy moreover are debatable. Nineteen
thousand cases of ovarian cancer and 11,700 deaths from ovarian cancer; have been
reported in 1987. Ovarian cancer is responsible for 4 percent of all cases of female
cancers and 5 percent of all deaths from female cancers and 52 percent of deaths
from gynecologic cancers. The latter is the more significant statistic. Although ovar-
ian cancer is k)w in incidence, it is high in mortality since ovarian cancer is usually

detected at its later stages. Sixty to 70 percent of all cases have reached at least
stage 3 at the time of presentation and the overall 5-year survival rate for ovarian
cancer during years 1977 to 1982 was 37 percent, only a slight improvement com-
pared with previous decades.

In the United States the lifetime risk of developing ovarian cancer is one out of
70 women, or 1.4 percent but and it is estimated that one out of every 100 women
will die of the disease.

There are hereditary conditions that are believed to be autosomal dominant traits
and are associated with a 50 percent risk of ovarian cancer. If a patient has first
degree relatives with cancer of the breast or ovary she should be considered for hav-
ing one of these syndromes and a history of breast, endometrial, or colon cancer also
increases the risk of ovarian cancer. Therefore, bilateral oophorectomy is considered
even in women under 40 years of age who have finished child bearing or who do
not desire child bearing to prevent ovarian cancer if they fit one of these cate^ries.
Removal of one ovaiy at the time of hysterectomy does not decrease a woman s risk
of ovarian cancer. Ovarian cancer is decreased by cessation of ovulation either by

Sregnancy or prior oral contraceptive use and an increase in the number of children,
iral contraceptive use for at least 3 months decreases the relative use to .6 and
use for more than 5 years of oral contraceptives decreases the relative risk to .4.

It is estimated that 700 prophylactic oophorectomies would be required to prevent
one case of ovarian cancer. However, prophylactic oophorectomy does not offer com-
plete protection against ovarian cancer since ovarian cancer can develop in peri-
toneal tissue and therefore interabdominal carcinomatosis can develop in coelomic
epithelium and therefore patients with bilateral oophorectomies are stiU at risk for
developing ovarian cancer.

Nevertheless, when ovaries are left behind after a bilateral oophorectomy they
may scar down and create symptoms. Reoperation occurs within 5 years of hyster-
ectomy in Vz of these cases. A major symptom of this is severe pain and the findings
usual^ include pelvic adhesions, corpus luteum cyst, endometriosis, benign ovarian
tumors, and, in rare cases, ovarian malignancies.

A major disadvantage of elective oophorectomy is the fact that if a woman is
younger it mandates that she be treated with hormone therapy at least till age 50.
Since the hormone replacement therapy is complex and not necessarily entirely
physiologic, thought should be given concerning the benefits of removing a residual
ovary Byndrome or the potential risks of developing ovarian cancer in the future.

THE PAUCITY OF RESEARCH AND INFORMATION ON THE CONDITIONS THAT ULTIMATELY

LEAD TO HYSTERECTOMY

Data gathering in the regard is inconclusive. The designations in terms of the
data from the Nationsd Hospital Discharge Survey may be inexact due to different
nomenclature and different diagnostic disease categories indicated on discharge
summaries. Many hysterectomies may be associated with negative pelvic pathology.
In these cases the preoperative evaluation, both medical and psychological, is impor-
tant since many Of these patients with chronic pelvic pain may have other causes.

In the United States 33 percent of women have a hysterectomy by age 65. In Eng-
land and Sweden the rate is 17 percent. Therefore, it is important to question why,
we as a western civilized society are so different. The needs of the female patient
in our country may be different or the provocation to use a surgical approach may
be greater. Indications for hysterectomy are to safeguard life through the control of
disease, to relieve symptoms and suffering, to realign pelvic anatomy and to restore
physiologic function.

It's important to realize that hysterectomy is an important component of women's
healthcare since it does prevent disease and does alleviate symptoms. Evaluating
criteria for hysterectomies and ranking diagnoses which need precedence over oth-
ers is difficult to since many of the symptoms leading to hysterectomies are related
to pelvic pain, and dysfunctional bleeding and are not necessarily associated with
definite anatomic pathology. Quality of life issues in the individual with pelvic pain,
uncontrollable bleeding, should also be taken into account. Alternatives for hyster-
ectomy due to anatomic causes or nonanatomic causes need further research. This
involves the use of medical therapy such as LHRH agonists for both endometriosis
and fibroids.

THE INEFFICIENT OUTCOMES DATA ON THE RISK, BENEFITS AND OVERALL
EFFECTIVENESS OF HYSTERECTOMY IN SURGICAL AND MEDICAL ALTERNATIVES

There are current studies on hysterectomy, some of which have been reviewed by
the ACOG task force reported to the executive board on July 1990. The New York
State hysterectomy rate is very low and below that of the entire Northeast region

which is abeadv on the low side. The average age of hysterectomy is also higher
in New York than the rest of the country. The North Carolina Appropriateness
Study is still pending. TTiis was composed of 9 North Carolina Obstetriaan Gyne-
cologists who served on a practice pattern variations committee. The project identi-
fied low, medium and high rates oi hysterectomies in various North Carolina coun-
ties and selected medicaf records from a random sample of hospitals from each cat-
egory. The charts were then reviewed and compared in attempt to measure appro-
priate and inappropriate indications for hysterectomies. The third current collabo-
rative review is of sterilization procedures (Crest), at the CDC is currently analyzing
this data. This study will define a woman's recollection of the main reason for un-
dergoing hysterectomy with her impression of how effective the surgery was in re-
solving the problem. It will determine how a woman believes that hysterectomy ef-
fected her sexual interest or pleasure, and also determine how a woman believes
a hysterectomy effected her overall general health in preventing future pregnancy.
The fourth is the Maine Study of Hysterectomy Outcomes, which is a prospective
study of outcomes of hysterectomy and alternatives to treatment for nonmalignant
conditions. It was ftinded by the National Center for Health Services Research and
it is still underway. It is a 3-year project and it is a prospective folio wup study of
women ages 25 to 35 presenting to gynecologists throughout Maine. The study is
comparing the results of 500 women undergoing hysterectomy for nonmalignant con-
ditions with those of 400 women who are receiving no treatment or medical treat-
ment only for fibroids, dysfiinctional uterine bleeding and pelvic pain. Therefore,
this will be a direct comparison between the surgical and medical approaches to
hysterectomy. The study will access the effect of hysterectomy and other treatments
on symptom relief and quality of life. The study also includes the decision analysis
to examine the risk benefit tradeoffs of surgery under specific clinical circumstances.
Other models are also available, including peer review practices such as in the State
of Masstichu setts A peer review process was established in 1977 recpiring Medicaid
recipients to obtain a second opinion before elective surgical operations. Of 367 pa-
tients sampled once in metropolitan Boston who underwent 1 or 2 consultations re-
garding hysterectomy, 87 percent received second opinions recommending hyster-
ectomy and for another 13 percent a recommendation for medical management was
the reason most often given by consulting physicians for not approving hyster-
ectomy. Of those patients who received second opinions favoring hysterectomy, 75
percent went on to have the operation and 10 oi 13 patients who received 2 rec-
ommendations against any gynecologic surgery still went on to have the operations.
Two-thirds of the initially negative second opinions were reversed when a third
opinion was obtained. In Saskatchewan Province in Canada a wide review of
hysterectomies was made in 1972. A list of established indications for hysterectomy
by the College of Physicians and Surgeons Committee evaluated a percentage of op-
erations justifiable against their criteria. The percentage of unjustified
hysterectomies performed in 7 hospitals fell from 24 percent between 1970 and 1973
to 8 percent in 1974. Overall, the total number of hysterectomies in the province
decreased 33 percent from 1970 to 1974

Cost effectiveness studies have also been made for elective hysterectomy. This is
an important consideration since the cost of a one time surcical procedure including
hospital stay has to be accessed against the lifetime cost oilong-term medical man-
agement and the possible recurrence of the disease. Such statistics are not forthcom-
ing. The benefits of elective hysterectomy at age 35 theoretically would include de-
tection of an unsuspected but treatable nonuterine pathology and avoidance of in-
convenience and discomfort of menstruation.

The morbidity and mortality of elective hysterectomy also needs to be assessed.
The mortality from hysterectomy is quite low. In 1985 one study showed the mortal-
ity rate to be 6 per 10,000 procedures not associated with pregnancy or cancer relat-
ed hysterectomies. The mortality rate associated with hysterectomy increased with
age and was twice as high for black as for white women. The 1982 Collaborative
Review of Sterilization (Crest), which was a prospective multicenter observational
study coordinated by the CDC reported that between September 1978 and August
1981, 1,851 women ages 15 to 44 from 9 institutions underwent hysterectomy dur-
ing the 3-year period of 1978 to 1981. There was a 1.7 times greater risk of com-
phcations with abdominal hysterectomy than with vaginal hysterectomy. However,
the confounding issues may be that a vaginal hysterectomy is usually done in the
less difficult medical and surgical situation and that vaginal hysterectomies are as-
sociated with a greater use of prophylactic antibiotics. Dr. Peter Braun evaluated
the effect of hysterectomy or hysterectomy and bilateral salpingoophorectomy versus
alternative medical management on life expectancy, quality of life and direct medi-
cal costs. Gains, rather small ones, in Ufe expectancy and quality of life in women
30 to 60 who underwent hysterectomy for benign neoplasm, disorders of menstrua-

tion, acquired abnormal anatomy, cervical disease or endometriosis. The benefits
were due primarily to prevention of reproductive tract cancers, which outweighs op-
erative mortality. In other words, healthy 40 year-old women undergoing hyster-
ectomy alone can expect an average gain of 2 months. If the ovaries are removed
also and estrogen replacement therapy initiated postoperatively, the age gain was
5 months. Women younger than 35 not treated with replacement estrogens following
hysterectomy and oophorectomy can expect net losses of life expectancy due to in-
creased risks of heart disease and osteoporosis.

THE LACK OF INFORMATION ON THE LONG-TERM PHYSICAL AND PSYCHOLOGICAL
CONSEQUENCES OF HYSTERECTOMY

This title overlaps with the previous one. One of the major concerns is the psycho-
logical sequelae of hysterectomy. In 1970 Richards coined a term post hysterectomy
syndrome. Approximately 36 percent of all hysterectomies are done with bilateral
oophorectomy. However, Richards found symptoms of hot flashes, fatigue, headache,
urinary symptoms, dizziness and insomnia. This may be confounded by the fact that
he did not take into regard that many of the women probably had oophorectomy.
Depression has been reported most frequently postoperatively with hysterectomy
with anywhere from 4 to 23 percent of women citing this complaint in studies with
followup periods ranging 3 months to 5 years. It is important to know whether or
not the ovaries were removed because this can create problems with reactive depres-
sion from lack of sleep and hot flashes. The incidence of sexual dysfunction after
hysterectomy ranges from 10 to 46 percent depending on the patient cohort. The de-
tails of the survey, the inclusion of patients with cancer or other serious diseases
and the performance of removing both ovaries affect the outcome of these surveys.
Richards, in a contrary fashion, found that 9.5 percent of women who had
hysterectomies were pleased postoperatively and that 38 percent felt better sexually
afterwards. Because hysterectomies are performed on women over 45 years of age
it is certainly possible that the operation is incorrectly held responsible for the natu-
ral decline in sexual activity with aging. To minimize these postoperative problems
the patient's psychological makeup needs to be evaluated as well as the physical
problems that have led to the possibility of a hysterectomy. Particular attention
should be given to women with a psychiatric history and those who seek hyster-
ectomy for alleviation of symptomatology related to the pelvis with absence of de-
monstrable pathology. Those under 30 years of age and those having infrequent
intercourse are more vulnerable to the adverse cycle sexual outcomes. The post-
operative cycle sexual problems with hysterectomy appear to be more prevalent in
patients with:

1. preoperative history of depression, sexual dysfunction and other psycho-
logical disturbances

2. age less than 35-40 years, limited education or conflict about future child-
bearing

3. poor preoperative understanding of the proposed surgery and what changes
to expect postoperatively

4. belief that the uterus has unique psychological and sexual importance

5. the absence of pelvic pathology

In conclusion, we do have alternatives to hysterectomy. However, we do not have
conclusive studies on these less definitive treatments. \N^at is the medical expenses
involved, in other words, with long-term LHRH agonist therapy (high cost of the
medicine, multiple office visits, probability of disease recurrence)? The management
of patients with pelvic pathology or pelvic pain needs to involve the entire patient,
her psychology, her social environment, her specific diagnosis and its prognosis for
recurrence. Patient education is important so that patient choice can be made with
informed consent. Needless to say, the patient has to be treated as an individual
and a decision regarding medical therapy vs surgery must be made regarding her
needs. A sexual and psychologic history is also important preoperatively to under-
stand the patient's fears and views of herself after "castration". Hysterectomy rates
do need to be critiqued and decreased for unnecessary indications. Nevertheless, the
OB-GYN is not entirely at fault for this phenomenon. The national government has
not in the pat funded studies to analyze the life history, aging and hormonal
changes in the uterus and ovaries and so our knowledge base is deficient for medical
management. This leads to the use of hysterectomy for a definitive cure in the pa-
tient and for peace of mind in the physician fearful of legal implications.

REFERENCES

ACOG Technical Bulletin. Number 111, December 1987. Prophylactic

oophorectomy. , i:, n

Bachmann GA. Psychosexual aspects of hysterectomy. WHI Vol. 1, No. 1 Fall

1990.
Carlson FJ, Nichols DH, Schiff I. Indications for hysterectomy. N Engl J Med

1993;856-60.

Easterday CL, Grimes DA, Riggs JA. Hysterectomy in the United States. Obstet
Gynecol 1983; 62:203-12.

The American college of Obstetricians and Gynecologists. Report to the executive
board from task force on hysterectomy. 1990.

Senator Mikulski. Now we'd like to turn to a very distinguished
physician, Dr. George Morley, who was past president of the Amer-
ican College of Obstetricians and Gynecologists, and he is currently
at the University of Michigan Medical Center in the department of
obstetrics and gynecology. And I believe you also held an academic
chair, if I'm not mistaken. Dr. Morley.

Dr. Morley. That's correct.

Senator Mikulski. So you, too, bring the experience of a clini-
cian, a scholar, and someone who has represented the American
College of Ob-Gyn specialists, and we look forward to hearing your
assessment of this situation and your recommendations.

Dr. Morley. Thank you. Senator Mikulski.

It is truly a pleasure for me to be here before the subcommittee
discussing hysterectomy, an issue of great importance to women
and their physicians. This has been and remains a controversial
subject, and rightly so. As the second most frequently performed
major surgery in the United States today, we should be concerned
that so little research has been conducted on the indications of hys-
terectomy, the alternatives to hysterectomy, and finally, the out-
comes of hysterectomy, especially its long-term impact on the qual-
ity of life for women.

At this time, let me focus on the question: Is hysterectomy nec-
essary? In short, yes. Hysterectomy is necessary for >vomen diag-
nosed with uterine cancer, as well as for women suffering from se-
vere symptoms of a noncancerous condition such as abnormal uter-
ine bleeding, endometriosis, or symptomatic pelvic relaxation that
may have previously failed medical treatment.

For many women this these conditions, hysterectomy is the one
treatment option that provides them with significant relief from
their symptoms, and in most instances it allows the woman to re-
gain better control of her life.

Most hysterectomies, I believe, are performed for well-docu-
mented indications and in accordance with the ACOG quality as-
surance guidelines. These criteria serve as basic guidelines for ob-
stetrician-gynecologists about what should be done in diagnosing
and treating patients with noncancerous gynecologic conditions. By
using these criteria, hospital quality assurance reviewers should be
able to judge whether proper care has been delivered, and if not,
why not. Again, these ACOG criteria establish a threshold of care
below which most physicians would agree care was substandard.

Allow me to shift gears for a moment and talk to you as a prac-
ticing physician about the well-being of some of my patients who
chose hysterectomy after more conservative treatments failed to
improve their symptoms.

A few years ago, a 42-year-old schoolteacher came to me com-
plaining of chronic pelvic pain. The symptoms were causing her to
miss several days of school per month. After taking medication over
a long period of time that failed to improve the condition, we did
begin discussing the possibility of hysterectomy. She was anxious
to De rid of the severe pelvic pain and was not interested in having
any more children. I counseled her thoroughly about the risks of
hysterectomy and felt confident that she understood fully the pro-
cedure. Recently, tiiis patient told me that she had not missed a
day of classroom teaching since her hysterectomy 4 years ago.

Another patient of mine, a 37-year-old woman with five children,
suffered from severe endometriosis. Pelvic endometriosis is another
noncancerous condition that, while not life-threatening, is a very
painful and often debilitating disease. For this woman, it made it
impossible for her to manage her household activities. She tried
hormonal therapy for several months, to no avail. The symptoms
persisted, and we discussed her options at that point. Sne chose
hysterectomy and remarked recently that 4 more hours of produc-
tivity had been added to each day of her life since her hyster-
ectomy.

While these are but two examples of patients satisfied with their
decisions, I find this common for many women who have had
hysterectomies for noncancerous conditions that were adversely af-
fecting their ability to function as they normally would at work and
at home.

It is interesting to note that the median age for hysterectomy is
40, an age at which many women are extremely busy with their
families and their work. Only after all medical options and conserv-
ative surgical procedures have failed to relieve the woman of her
symptoms should the patient and her physician seriously consider
hysterectomy, its risks and its benefits.

Hysterectomy remains an effective treatment for many women,
returning a sense of normalcy and control to their daily living.

One of the most critical aspects of hysterectomy is its long-term
impact on women's quality of life. This is an important factor in as-
sessing the effect of hysterectomy on the patient's overall well-
being. Yet there are no reliable studies on lon^-term outcomes of
hysterectomy, limited studies on the natural history of conditions
leading to hysterectomy, and no studies on the long-term effective-
ness of alternatives to hysterectomy. Research in these areas has
been lacking, and we strongly urge Congress to devote the nec-
essary resources to such research.

Madam Chair, I appreciate your interest in hysterectomy, and as
a practicing physician, I ask that you and your colleagues assure
that Federal research funds are made available so that we have
better information in the future for assessing when to do a hyster-
ectomy and when not do to a hysterectomy.

Thank you very much.

Senator Mikulski. Thank you. Dr. Morley.

[The prepared statement of Dr. Morley follows:]

Prepared Statement of George W. Morley

Madame Chair, members of the subcommittee, I am George W. Morley, MD, past
president of the Axnerican College of Obstetricians and Gynecologists (ACOG) and

the Norma F. Miller Professor of Gynecology at the University of Michigan Medical
Center in Ann Arbor, MI.

I appreciate this opportunity to appear before you on behalf of ACOG, an organi-
zation representing more than 33,000 physicians providing women's health care, to
discuss a issue of immense importance to women's health ad well-being: hyster-
ectomy. The increased attention on "unnecessary hysterectomy" and alternatives to
hysterectomy is appropriate. Rather than asking whether there are too may or too
few hysterectomies performed in the United States, we should be asking the follow-
ing: first, are women who need hysterectomies getting the surgery, and second, are
hysterectomies always indicated? ACOG continues to seek answers to these ques-
tions and we believe this bearing will prompt much needed research in the area of
hysterectomy indications ad outcomes, particularly its impact on women's overall
quality of liie, which we contend is a primary consideration in the woman's decision
to undergo a hysterectomy.

At the outset, let me speak briefly to the "quality of life" issue as it relates to
hysterectomy. T\us aspect of hysterectomy is one of the most important factors going
into the patient's decision about whether a hysterectomy is right for her. As 1 wul
discuss in more detail later there are several benign conditions for which hyster-
ectomy is indicated, once all medical treatments have failed to improve the condi-
tion. These include abnormal uterine bleed chronic pelvic pain' vaginal prolapse,
and others, which often cause painful and severe symptoms for may women diag-
nosed with these ailments. While these conditions are not life-threatening and usu-
ally do not pose a serious risk to a woman's health, the symptoms can be so severe
as to impair a woman's ability to function as she normally would at work and at
home. Women today are major breadwinners for their families and all too frequently
are heading up single-parent households. For most women, the demands of working
40 to 60 hours a week ad raising a family are greatly disruptive and even intoler-
able if she must endure bouts of abnormal bleeding and persistent chronic pain. For
a majority of women with these conditions, hysterectomy eliminates permanently
the symptoms, returning a sense of normalcy and control to the patient s life. Thus,
may women dioose hysterectomy since it provides them with an improved quaUty
of life on several fronts.

In ACOG's role as a scientific and educational resource for obstetrician-gyne-
cologists throughout the country, we have developed quality assurance criteria for
various obstetric and gynecologic procedures. Copies of those criteria relating to the
gynecologic conditions for which hysterectomy may be indicated are attachea. These
criteria serve as basic guideUnes for obstetrician-gynecologists about what should ad
should not be done in the diagnosis and management of patients with specific ob-
stetric and gynecologic conditions. These criteria differ from the clinical indicators
in that they are intended to help in the evaluation ad measurement of the quality
and appropriateness of care, not just the identification of areas for further study.
In creating the criteria sets, ACOG was attempting to describe a threshold of pro-
vider care oelow which most physicians would agree that care was substandard.

In an attempt to establish an information base, in 1988, ACOG formed a task
force on hysterectomy which, over a period of 2 yesirs, eyed data from the National
Center for Health Statistics (NCHS), conducted an extensive literature review on
hysterectomy (incidence, indications, and decision criteria), and also examined stud-
ies then underway in a variety of settings. The task force did not attempt to gen-
erate new data, to describe or promote surgical techniques, or to outline treatment
of complications to hysterectomy. The task force drafted a report of its findings that

{>ointed to research needs to address specific questions about clinical indications,
ong-term follow up of alternative treatments, and quality of life issues.

BACKGROUND

Approximately 600,000 hysterectomies are j>erformed each year in the United
States and by the sixth decade of Ufe more than one-third of all women in the Unit-
ed States have undergone the procedure. From 1975 to 1987, the rate of hyster-
ectomy declined from 8.6 per 1,000 women to 6.7 per 1,000. In 1990, the rate of hys-
terectomy was 5.8 per 1,(K)0 women, but this rate cannot be compared directly with
previous rates since the National Hospital Discharge Survey (NHDS) was rede-
signed and surveyed a new sample of hospitals starting in 1988.

The mortality rate from hysterectomy is quite low. A 1985 study calculated the
risk of death to be 6 per 10,000 procedures when the hysterectomy was not associ-
ated with pregnancy or cancer. This rate is among the lowest for major surgical pro-
cedures in the United States.

However, there is an increased risk for older women, ad the mortality rate is
twice as high for African-American as for white women. Overall, abdominal hyster-

ectomy is associated with more complications than vaginal, usually because the ab-
dominal route is chosen more often in difficult cases, or when extensive disease or
cancer may be encountered. • i. i tt ^

There is considerable variation in the frequency of hysterectomy withm the Umt-
ed States and among countries. In 1987, NCHS reported that the hysterectomy rate
in the Northeast was 4.1 per 1,000; in the Midwest, 6.5 per 1,000; in the West, 8.1
per 1,000; an in the South, 7.4 per 1,000. Hysterectomy rates among countries vary
widely: more than one-third (37 percent) of women in the United States have had
a hysterectomy by age 65 whereas only 17 percent of women in England or Sweden
have had a hysterectomy by this same age. A 1984 demographic study reported that
the life expectancy for women in the United States, England, and Sweden at age
40 ad at age 55 were essentially the same at 80-82 years for all three countries.
Which rate is right once all factors are analyzed is still unanswered. It is at this
juncture that quality of life becomes a pivotal issue with outcome studies being
needed to compare patients having hysterectomy to those not having the sui^gery
given the same medical condition and symptoms.

INDICATIONS FOR HYSTERECTOMY

Most hysterectomies are performed for well documented indications ad in accord-
ance with quality assurance guidelines. One must caution against being too conserv-
ative since one may overlook a significant indication for its performance and thus
give rise to adverse health consequences. n i • i •

Because there are insufficient scientific data available to support all clinical situa-
tions relating to some of the indications for hysterectomy, the physician's clinical
impressions as well as the patient's desires must be considered when decisions to
perform hysterectomy are made. For example, for patients with benign conditions
such as fibroids, uterine prolapse, abnormal uterine bleeding, chronic pelvic pain or
endometriosis, hysterectomy is appropriate only if the condition has proven resistant
to more conservative nonsurgical or surgical management.

Counseling patients about the risks and benefits of hysterectomy and alternative
treatments, and establishing informed consent for the treatment option are critical
aspects in assessing whether hysterectomy is indicated and appropriate. More than
one counseling session for a patient considering hysterectomy is necessary to assure
that she is fuUy informed and comfortable with her decision. When counseling a pa-
tient, the physician may provide written materials about hysterectomy, which may
help the patient to understand her choices and their implications. This allows the
patient to absorb the information at home and will help her gain a thorough under-
standing of the procedure, its potential comolications and benefits. ACOG has pub-
lished a patient education pamphlet entitled, ,that examines the various issues sur-
rounding hysterectomy, as well as patient education pamphlets on each of the be-
nign conditions, which explain the treatment options available before hysterectomy
is considered. In my experience, the ideal patient is one who is well-informed about
the options and asks many questions; only then can the physician really engage in
dialogue with the patient and help her determine what treatment is best for her.

Ultimately, the decision to go forward with a hysterectomy is the woman's and
the physician must be diligent in providing her with information about all alter-
native treatments for her condition. For women who undergo an oophorectomy (re-
moval of the ovaries) at the time of the hysterectomy, they must also weigh the op-
tion of hormone replacement therapy. I will now discuss some of the conditions that
often lead to surgery ad explain why and when hysterectomy is considered the ap-
propriate course of treatment for some women.

Uterine Fibroids

This diagnosis constitutes the single most common indication for hysterectomy in
the United States, accounting for 80 percent of the hysterectomies between ages 35-
55 years. Fibroids are benign growths on the wall of the uterus that usually do not
cause symptoms nor require removal, but may cause the uterus to enlarge consider-
ably. I should note that fibroids are present in almost 30 percent of all women over
30 years of age tmd most are of no serious consequence.

Once the ffljroids have caused the patient's uterus to enlarge to at least the size
of a 12-week pregnancy, then hysterectomy becomes a consideration. An enlarging
uterus can obstruct access to the ovaries for purposes of detecting ovarian cancer,
and at times block the ureters causing pressure on the kidneys. Furthermore, the
larger the woman's uterus becomes, the greater the likelihood that she would have

though this is rare, or that the mass is a different growth and not a fibroid after
all.

Not all fibroids continue to grow or cause symptoms, so for may women with
asymptomatic fibroids, treatment will probably not be necessary. In these patients,
the fioroids can be safely monitored through periodic pelvic examinations to detect
any changes, since by the time the patient reaches menopause, the fibroids will uni-
formly shrink in size.

Myomectomy— the removal of the fibroid itself— is an alternative to hysterectomy
for some patients, particularly those who want to have children in the future. Com-
pared with hysterectomy, however, this procedure is more difficult to perform ad
there is a higher morbi<fity. Furthermore, fibroids mav develop again in the patient.
For these reasons, myomectomy is generally reserved for women who want to have
children in the future.

Uterine Prolapse

Hysterectomy is indicated in women experiencing advanced degrees of uterine
prolapse where a portion of the uterus or both the cervix and the uterus descend
through the vaginal opening. These patients report symptoms of pelvic heaviness,
pressure in the pelvis, a feeling that the pelvic organs are "falling out," and the ac-
tual sensation tnat tissue is protruding through the vaginal opening or that there
is a bulge at the opening into the vagina.

It becomes more difficult to assess whether hysterectomy is warranted for women
experiencing a lesser degree of prolapse where only the cervix descends to near the
vaginal opening. In many instances, patients are able to adjust to this lesser degree
of prolapse within a short period of time with a remission of symptoms, and depend-
ing on me woman's desire for children, she may be treated with pain medicines to
include nonsteroidal drugs during those times when she is suffering from the symp-
toms described above. In general, hysterectomy is rarely indicated for women diag-
nosed with asymptomatic pelvic relaxation and mild uterine prolapse.

For a patient oiagnosed with only mild relaxation and whose only complaints are
those related to urinary incontinence, she must be thoroughly tested for urinary in-
continence before making a treatment recommendation. In some cases, depending
on the woman's age, hormone replacement therapy can be effective as a nonsuivical
treatment for stress urinary incontinence and topical estrogen applications have
been prescribed as well. The woman and her physician may also decide upon a 3-
to 6-month's trial of exercises to stren^hen the pelvic muscles (otherwise known as
Kegel's exercises), which may be efiective in relieving the symptoms.

Abnormal Uterine Bleeding

In women experiencing abnormal uterine bleeding of an unknown cause, exclud-
ing fibroids, hysterectomy is considered only if the bleeding is severe, recurrent, and
unresponsive to other methods of treatment, such as hormonal therapy and a dilata-
tion and curettage (D&C) procedure.

Except in rare instances, patients under 35 years of age should always be treated
with hormones before any sui^ery is performed. For women 35 ad older, an
endometrial sampling should be performed prior to hormonal therapy to rule out or-
ganic or cancerous causes of the abnormal oleeding. If the abnormal uterine bleed-
ing persists, the patient should undergo a D&C, usually on more than one occasion
before hysterectomy is seriously considered by the patient and her physician. How-
ever, the literature published during the last 20 years does not report outcome re-
sults of D&Cs for tine long range control of abnormal uterine bleeding; however,
anecdotally, a number of women nave never had any bleeding after a D&C has been
performed.

Currently, endometrial ablation (destruction of the endometrial lining of the uter-
us) is being used as an alternative to hysterectomy for some patients who are resist-
ant to conventional therapy. However, the long-term effectiveness of this technique
ad the potential for masking cancer in later life are not known.

Chronic Pelvic Pain

The treatment of patients complaining of chronic pelvic pain in the absence of a
malignancy may prove very diilicult to manage effectively. Generally speaking,
there are two duagnoses for chronic pelvic pain: those patients experiencing recur-
ring dysmenorrhea (difficult and painful menstruation) and those complaining of
chronic pelvic pain that is totally unrelated to the menstrual cycle.

Symptoms of dysmenorrhea usually occur during the early reproductive years. As
a guideline, except under unusual circumstances, no patient under age 30 should
undergo hysterectomy for this complaint without first undergoing medical forms of
treatment, such as Ibuprofin for several months. K that is not effective, the patient
should use oral contraceptives for another few months. The patient should be treat-

ed medically for at least a 6- to 9-month period before surgery is considered. The
effects of dysmenorrhea on a woman's social and economic well-being are far-reach-
ing, affecting her overall quality of life, her day-to-day productivity, and potentially
her job. If the symptoms are not alleviated by medication, hysterectomy may be con-
sidered by the patient, but this should always be considered the treatment of last

Patients experiencing chronic pelvic pain not associated with menstruation should
underao the same secpience of treatment options outlined above. Hysterectomy is
consi<fered only after the patient's condition has not improved and has been unre-
sponsive to all intermediate, nonsui^cal treatments, including hormonal therapy.

Pelvic Endometriosis

Endometriosis is a condition in which tissue that looks and acts like the lining
of the uterus is found outside the uterus, growing on the ovaries, fallopian tubes,
and other pelvic structures. During each menstrual cycle, these patches of
endometrial tissue undergo cyclic changes just like a menstrual cycle within the
uterus.

For a woman with extensive endometriosis which has failed to respond to hor-
monal therapy and conservative surgery, hysterectomy as well as oophorectomy may
be necessary. Patients should take oral contraceptives or progestins, for example, for
at least 3 to 4 months. K the endometriosis persists, then the woman ad her physi-
cian may discuss surgery to remove or destroy the endometrial growths. If the pa-
tient continues to experience severe endometriosis, then a hysterectomy^ ad an
oophorectomy are appropriate and, I would argue, warranted for the patient's phys-
ical well-being. Endometriosis is a very painful and often debilitating disease, and
for many women having a hysterectomy improves their quality of life.

HYSTERECTOMY OUTCOMES

The quality of life subsequent to hysterectomy is one of the important markers
in assessing the effect of the surgery on the patient's physical well being as well
as its impact on her psychological and sexual well being, and in her day-to-day
sense of well being. The patient benefits from the hysterectomy in that the fibroids,
endometriosis or other condition that caused her to have the surgery will be eradi-
cated; she will no longer menstruate; the dysmenorrhea will be eliminated; and the
fear of cancer of the uterus — assuming the cervix is also removed — is also elimi-
nated. All of these factors contribute to an improved quality of life for the patient.
Unfortunately, there are few good outcome studies analyzing the pre- or post-
operative comparisons as they relate to these issues. For the most part, these stud-
ies have focused on the psychological impact of hysterectomy and few have studied
the physical and sexual effects of this operation.

The psychosexual functioning of women after hysterectomy is frequently a subject
of concern. According to the studies that have been conducted to date, most women
are completely satisfied with the results of their hysterectomy and their resjponses
to it, yet there are those patients who report significantly higher levels of depres-
sion, physical and psychological symptoms, and sexual or marital problems subse-
quent to the surgery. Some researchers contend that these complaints preceded the
surgery on these patients but that they probably never had the opportunity to give
voice to these complaints beforehand. These findings may have implications for
managing patients about to undergo hysterectomy by indicating the need for more
targeted counseling before the surgery. Patients should be warned that everything
may not be fme following the hysterectomy.

RECOMMENDATIONS: RESEARCH PRIORITIES

As I have mentioned repeatedly throughout my statement, additional research is
needed regarding alternative therapies to hysterectomy for benign conditions and
the impact of various options on a woman's quality of life. Hysterectomy is the sec-
ond most frequently performed major surgical procedure in the United States, and
yet there are no large-scale, reliable long-term outcome studies, no longitudinal data
on the natural history of conditions leading to hysterectomy, and no studies on the
long-term positive ad negative effects of alternatives to hysterectomy.

Large-scale, reliable studies should be conducted to:

• Assess the long-term results of hysterectomy on health and quality of life.

• Detect the adverse effects that may follow hvsterectomv.

• Determine the natural history of conditions leading to hysterectomy.

• Evaluate the effectiveness of alternatives to hysterectomy.

• Identify reliable and valid measurement techniques for assessing physical,
psychological, sexual, and functional outcomes related to hysterectomy.

• Understand the spectrum of attitudes held by women regarding both symp-
toms and surgery.
We urge you to allocate appropriate Federal funds to research in these areas.

CONCLUSION

In most cases hysterectomy is performed in the absence of a life-threatening dis-
ease, such as uterine cancer, for well documented indications. As I mentioned ear-
lier, the rate of hysterectomy in the United States has remained relatively constant
during the last several years. Due to the numerous variables associated with hyster-
ectomy, however, it is impossible to assign an appropriate or ideal rate for the pro-
cedure. Federal or State legislation will not change this ad we urge Congress to tar-
get resources to promote and support research concerning all aspects of hyster-
ectomy: indications, alternatives, and outcomes.

Medicine in general is in a constant State of transition ad this is at it should be.
The indications for hysterectomy have and will continue to change as we improve
our understanding of the pathophysiology of these diseases and disorders, and can
identify alternatives to hysterectomy through new technologies and treatments.
After the preoperative assessment and counseling of the patient has been done, the
diagnostic steps have been taken and the therapeutic trials have been conducted
there will be improved insight into the necessity for hysterectomy. Postoperatively,
the patient may well have an opportunity for an improved quality of life, including
elimmation of troubling symptoms.

As primary care physicians for women, obstetrician-gynecolopsts strive to im-
prove women's health care, provide them with complete information about all treat-
ment options, and make every effort to ensure that each patient is thoroughly in-
formed about each treatment option. Hysterectomy is the second most frequently
performed major surgery in the United States and as such deserves increased study.
ACOG strongfy supports further research in this area and urges Congress to provide
funds for such research.

Procedure! Hysterectomy, abdominal (68.4) or vaginal (68.5)

Indication: Lelomyomata (218.0-218.9)

Confirmation of Indicationi

Presence of 1 or 2 or 3 or 4

1. Asymptomatic myomata associated with a uterine size equal to or larger than
■ that aJfter 12 weeks of gestation,* determined by physical examination or ul-
trasound examination

2. Excessive uterine bleeding evidenced by either a or b:

a. Bleeding for more than 8 days during more than a single cycle and profuse
bleeding' requiring additional protection

b. Anemia due to acute or chronic blood loss

3. Pelvic discomfort caused by myomata associated with a uterine size equal to
or larger than that after 12 weeks of gestation

a. Acute and severe

b. Chronic lower abdominal or low back pressure

c. Bladder pressure with urinary frequency not due to urinary tract infection

4. Rapid growth in size of uterus /myomata, to a point equal to or larger than
uterine size after 12 weeks of gestation

Actions Prior to Procedure:

1. ConRrm by cytologic study the absence of cervical malignancy

2. Obtain endometrial sample or perform D&C (when abnormal bleeding is pres-
ent)

3. Correct anemia

4. Consider patient's medical and psychologic risks concerning hysterectomy

Contraindication;

Desire to maintain fertility, in which case myomectomy may be considered

'Tramverte meuuremeni of it letst 8 cm or weight of 280 g or more (lee appendix C).
I For example, large cloti, guihei, Umltatioiu on activity.

Unless otherwise stated, each numbered and lettered item (except contraindication)
must be present.

Procedurei Hysterectomy, abdominal (68.4) or vaginal (68.5)*

Indication; Chronic pelvic pain in the absence of significant pathology (625.9)'

Confinnation of Indication;

1. No significant pathology found on laparoscopic examination

2. Presence of pain for more than 6 months with negative effect on patient's
quality of life

Actions Prior to Procedure;

1. Document failure of a therapeutic trial with, for example, one or more of the
following:

a. Oral contraceptives

b. Diuretics

c. Nonsteroidal antiinflammatory drugs

d. Induced amenorrhea

2. Evaluate the following systems as possible sources of pelvic pain:

a. Urinary

b. Gastrointestinal

c. Musculoskeletal

3. Evaluate patient's psychologic and psychosexual status and counsel

4. Confirm by cytologic study the absence of cervical malignancy

Contraindication:

Desire to maintain fertility

• Evaluation of ihe quality of care provided with thb procedure, when performed for the indication
lirted, will he possible through "trendini " See the dlscujtion of trending in chapter 1.

♦ Other dUgnoset that should also be evaluated according to these criteria Include pelvic congestion
(625.5); pelvic varices (456 5); uterine retroversion (621.6); congenital anomalies (752.3): mild
endometriosis (617-617.8); minimal pelvic adhesions (6H 6); broad ligament window (620.6); firtt-
degree uterine prolapse (61^-618 9); and mild adenomyosis (617.0).

Unless otherwise stated, each numbered and lettered Item (except contraindication)
mtut be present.

Procedurei Hysterectomy, abdominal (68.4) or vaginal (68.5)*

Indicationi Abnormal uterine bleeding in women of reproductive age (626 all, except
626.0, 626.1, 626.3, 626.5, 626.7)'

Confirmation of Indication:

1. History

a. Elxcesslve uterine bleeding

1. Bleeding for more than 8 days dtuing more than a single cycle

2. Profuse bleeding requiring additional protection'

b. No history of a bleeding diathesis or use of medications that may cause
bleeding

c. Negative effect on patient's quality of life

2. Failure to find on physical examination uterine or cervical pathology that would
cause abnormal bleeding

3. Laboratory data

a. No finding of endometrial neoplasia

b. No malignancy found in cytologic studies of cervix

4. No Rnding of endometrial polyps (by D&C, hysteroscopy. or hysterogram)

Actions Prior to Procedure!

1. Consider patient's medical and psychologic risks concerning hysterectomy

2. Determine that attempted hormone treatment (estrogen-progestogen) was not
successful

Contraindication:

Desire to maintain fertility

•Evtlutbon of the quality of ctre provided with this procedure, when performed for the indication
listed, win be pouible through "trending " See the discussion of trending in chapter 1.

I Other diagnoses that should also be evaluated according to these criteria Include menorrhagia (626.2,
627.0). hypermenonhea (626.2), dysfunctional uterine bleeding, menometrorrhagia (626.8), and
polymenorrhea (626 2).

t For example, large clots, gushes, limitations on activity.

Unless otherwise stated, each numbered and lettered item (except contraindicationl
must be present.

Procedure: Hysterectomy* (68.4) (68.5)

Indication: Pelvic relaxation (loss of support of uterxis, vagina,' and contiguous organs'*)

ConHnnation of Indication:

Spontaneous, symptomatic protrusion of the cervix or vagina and contiguous organs to
or through the introltus when standing or straining which, in the patient's opinion,
interferes with her quality of life.

Actions Prior to Procedure:

1. Document patient's symptoms and physical findings *

2. Document nomuJ cervical cytology

3. Evaluate abnormal uterine bleeding if present

4. Document, when appropriate, patient's agreement to sterilization

5. Consider patient's medical and psychologic risks concerning hysterectomy

6. Administer prophylactic antibiotics prior to vaginal hysterectomy for women of
reproductive age

7. If associated with symptoms of stress incontinence, appropriate evaluation and
preparation is added

Contraindication:

Known medical or psychologic risks outweigh the benefits

• Ev«lu«eon of th* quiUty of c«r» provided with this procedure, when performed for the lndlc«Hon listed, will b«
poMlble Ihrcugh »s$ewmenl of ongoing or repeti«ve pttterru of care ("trerullivg"). See the discussion of trending
In Chapter 1 of Quality Auunmit in Obilitria «ml Gynecology, 1989 edition.

' A repair of the vaglr^ is expected when a symptomatic cytfocele, rectocele, or enterocete also exists.

• Other diagnose* to be evaluated: uterine descensus (618.1), uterine proUpse (618.1, 618.4), eyslocele (7050),
rectocele (70.42), cnterocele (70.8).

Unless otherwise stated each numbered and leHcred item (except contraindications) must be
present.

Procedure: Abdominal hysterectomy' with or without adnexectomy (65.3, 65.4, 65.5, 65.6,
68.4)

Indication: Endometriosis (617.0, 617.1)

Confirmation of Indication:

Presence of 1 and 2, 1 and 3, or 1 and 4:

1. Prior detailed operative description or histologic diagnosis of endometriosis

2. Failure of conservative measures to control significant symptoms

3. Presence of persistent, significant adnexal mass

4. Significant Involvement of other organ systems, eg, ureteral or intestinal obstruction

Actions Prior to Procedure:

1. Attempt medical or corwervative surgical theraf>eutic trial or document
involvement of other organ systems

2. Confirm by cytologic study the absence of cervical malignancy

3. Obtain endometrial sample or perform D&C (when abnormal bleeding is present)

4. Consider patient's medical and psychologic risks concerning hysterectomy

5. Document discussion of implicadorw regarding ovarian fxinction, ovarian involve-
ment in the disease, castration, and probability of recurrence

Contraindication:

Patient's desire to preserve reproductive organs

■ Evaluation of the quality o( care provided with this prTx»dure, w^hen performed for the indication listed, will be
possible through assessment of ongoing or repetitive patterns of care ("trending"). See the discussion of trending
in Chapter 1 of Qualify Assurance in Obslrtries »nj Cynemiogy, 1989 edition.

Unless otherwise stated, each numbered and lettered Item (except contraindications) must be
present.

Senator MncuLSKl. Dr. Finn, I'd like to turn to you first. When
I look at your recommendations for research, there are 13 insti-
tutes at the NIH as well as some very crucial centers, like the Cen-
ter for Nursing. First of all, your office cuts across all the institute
lines, which is why your office is so important; you are looking at
the standpoint of the woman and her life, rather than does she
have osteoporosis or any number of other things — ^am I right?

Dr. Finn. That's right, because just looking at the issue of hys-
terectomy really does cross-cut a number of areas, and it is really
beautiful for me to be there and experience the collaborative efforts
and pulling together of people from across the institutes and cen-
ters to see where we can better coordinate our efforts and interact
between ICs, and that has been very exciting.

Senator MiKULSKi. Thank you. Dr. Finn, it was not my intention
to turn this into an appropriations hearing, but why not, vvhile we
are here. I would ask you, then, for your recommendations on
where vou think we could focus, not earmark, but at least in our
report language express some of the thinking that has emerged in
this hearing from the clinical community and so on — as well as the
authorizing committee, of which this is one. I am going to go first
to statistics and then recommendations for areas of researcn, and
then picking up on what Dr. Morley said.

We are about to reauthorize the National Center for Health Sta-
tistics. Now, that's not going to be a zippy thing, and I know
"Nightline" is not going to call me up to be on and talk about this,
and so on. But what seems to emerge is whether it is getting can-
cer rates, or whether it is identifying some of the issues raised
here, that we seem to have skimpy statistics, and we have not fo-
cused on some population groups. For example, we heard Ms.
Ele/s compelling testimony about African American women, and
the rather glib statement given to her that, "Oh, a lot of African
American women have fibroids."

I wonder what you would recommend to us in terms of that area,
or if you'd like to give it thought, because it seems to me that the
National Center for Health Statistics needs to be able to be a tool
that gfuides us in our research, identifying where there are needs
and where there might be certain populations at risk in certain
areas.

Dr. Finn. I can comment on that, because actually, in preparing
for this hearing, Mr. Bob Fokras, from NICHD came and worked
with us very (£ligently, and that's how we were able to get the
most up-to-date data, much of which has not yet been published.
And I can sav that some of my questions related to do we really
have racial differences in diseases related to hysterectomy, and
have we looked at some of the other data. And I can tell you that
what he has pointed out is that right now, they are collecting more
specific data in relationship to race as well as in relationship to
disease categories.

If you look at the old data, there is sort of a caveat, because actu-
ally, they have been collecting data on the basis of race since 1965,
but the data is coming from hospital discharge summaries, and not
all hospital discharge summaries provided that information. So I
think appropriately so, they decided in the past not to analyze that
data because it was not complete; but it is now being analyzed, and

there are two papers now being prepared by the CDC which should
give us more complete information, and I am looking forward to re-
ceiving that.

Senator Mikulski. Well, we look forward to your recommenda-
tions as well as the NCHS recommendations on what you think we
really do need as we reauthorize the National Center. They have
been doing an excellent job, but we think that their statistics-gath-
ering has to be more contemporary, and we look forward to your
ideas on that.

Now, also, one of the things that seems to nm through your tes-
timony as well as the other testimony is that we don't have re-
search on the normal processes that affect women, and probably
men as well, and our normal processes are looked at within the
framework of a disease model to be worked on. And I am speaking
specifically of menopause. And as the chair of the Subcommittee on
Aging, what we are looking at here on the Subcommittee on Aging
is life-cycle implications. Why is the Subcommittee on Aging hold-
ing a hearing on hysterectomies? Because a significant number are
done in women over age 40. So we wonder what your thoughts are
and whether you feel that there has been adequate attention or
funding focused on research looking at the natural processes of
women and how that might then be a clue so that when we do go
our disease orientation, either the prevention, containment, or cure,
well have that. Do you feel that is adequate attention, or do you
have to scrounge for that?

Dr. PiNN. Ill answer the last question you asked first. No, I don't
think there has been adequate attention in the past. Second, is it
important? Yes, we think it is extremely important to look at the
normal processes, and I like to address it as sort of the normal
processes across the life span of aging of women, because if we
don't understand the normal, we don't know how to address the ab-
normal, and in fact, that is the point made in our research agenda,
"Opportunities for Research on Women's Health."

But I am pleased to tell you that as a result of our thinking, our
research agenda from our document, and from the recent con-
ference which was held, sponsored by Aging along with the Center
for Nursing Research as well as our office, we are now about to
issue a Request for Applications calling for a comprehensive multi-
disciplinary research effort on the natural history of menopause,
and that includes both natural and surgical menopause, and the
role of that transition on women's a^ng and subsequent suscepti-
bility to disease. And I think this will be very important, because
this is an effort that is not going to be disease based, but really
is looking at what is a normal process in women, to better under-
stand it, and then in relationship to a better understanding of the
normal aging process, beginning premenopausal and looking at the
events leading to menopause and the changes that begin to occur
earlier, so that we have a better understanding actually of meno-
pause itself by looking at the changes that precede it, and will then
be in a better position to target more specific studies looking at
prevention measures as well as treatment and alternatives to sur-
gery.

Senator Mikulski. Well, we'll come back to that, and we intend
in this subcommittee to hold a hearing on the subject of menopause

itself. But I love the pamphlet that NIA is putting out, and I sent
for it under an assumed name. I was interested to see how soon
I'd get it and so on, and I received it in a very timely way and
found the language that was used was done so that ordinary folks
could read it, and it was very informative. It did not generate fear,
or make you feel that this was a terrible thing that was about to
happen to you. So I thought it was an excellent pamphlet.

Dr. Pnw. That's a tribute to my colleagues here, since I did not
do that; this was done within the Institutes. But we do get feed-
back occasionally from women who call our office, or whom I see
when I am out speaking, who tell me either about documents they
have seen which they think really are appropriate, and in other in-
stances— in fact recently, this week at the Breast Cancer Coalition
affair, some women were telling me that they felt some of the docu-
ments were not down to the level of language for some of the
women in some of the minority communities to understand. And at
least with that interchange and the fact that we are getting that,
we are in a position to go back and work to better define some of
those documents for public education where we need to do that.

Senator Mikulski. Let me turn to Dr. Ravnikar next. Dr.
Ravnikar, you talked in your testimony about the need to explore
alternative therapies, and in the process of articulating that, you
said that there has not been enough research done on the efficacy
of that. And also what seems to emerge is because the efficacy has
not been demonstrated, physicians are prudent about undertaking
it, and that insurance companies don't reimburse it. So that brings
me to research on efficacy.

Where within the Federal Government would that most appro-
priately be done, and is it being done, or how could we boost it?

Dr. Ravnikar. It is probably being done in part by looking at the
efficacy of LHRH aganist therapy, for instance, for the treatment
of fibroids.

Senator Mikulski. I'm talking about what agency looks at it. I
know that we look at the safety and efficacy of pharmaceuticals at
FDA, and I don't know everything about the Federal Government —
where does the safety and efficacy of surgical procedures and alter-
native modalities kind of get the "Good Housekeeping Seal of Ap-
proval," or at least an analysis of risks and benefits associated with
it?

Dr. Ravnikar. I think I would turn again to the Office of Wom-
en's Health Research and see how that can be coordinated between
the institutes of the NIH.

Senator Mikulski. No — right now, who would be doing it?

Dr. Ravnikar. Oh — at the present time, there are various soci-
eties within the American College of Ob-Gyn and the American
Fertility Society, the Society of Reproductive Surgeons, who have
now done a survey of all their practicing physicians to see how
many of them do use laser surgery and laparoscopic techniques in-
stead of hysterectomies. So I think the specialty itself is doing such
surveys. I misunderstood your question; I thought you were talking
about the government surveys.

Senator Mikulski. In other words — and I'll perhaps ask Dr. Mor-
ley and Dr. Pinn as well — if in fact there needs to be more research
on the efficacy of treatments that are alternative, both surgical and

medical, then where would that spot be that determines the effi-
cacy of these techniques?

Dr. Ravnikar. I think there are various sub-agencies in the
American College of Ob-Gyn that could do it as an obstetrician-gyn-
ecologist subgroup. The CDC has also gathered some statistics in
terms of the Kress study, looking at the efficacy of sterilization pro-
cedures, and from my understanding are currently conducting effi-
cacy studies in terms of hysterectomies. But I am not aware of any
study that looks at in toto the specific subgroup of surgery versus
medical therapy, for instance, in terms of fibroids or in terms of
uterine bleeding with electrocautery techniques.

So I think the studies are there, but in terms of a national agen-
cy funding those studies, I am not aware of any.

Senator Mikulski. Dr. Morley, where do you — and I use "you" in
the plural of you and the American College — look, in addition to
the scientific journals, to say, well, I'm convinced that this has effi-
cacy, these are the costs, and these are the benefits? Is there a gov-
ernment agency? For instance, in order for Tagamet to come to the
marketplace, if you look at FDA, then it would not come to the
market.

Dr. Morley. Well, I must say that as far as the American Col-
lege of Obstetricians and Gynecologists is concerned, we are not a
research institute. We are an educational institute. We establish
guidelines for various procedures, alternatives to hysterectomy, etc.
But to be more specific to your question, actually, the CDC that Ve-
ronica mentioned is certainly a very important place as an agency
for doing investigative work. And then I would turn to the National
Institutes of Health. Many of our people in our institutions and the
universities are applying for national grants through the NIH to do
research on these alternatives, and I am absolutely 100 percent in
support of research in these areas.

You know, medicine is in transition; it always has been in treinsi-
tion, and it will be in the future. I am actually excited about this
panel in the sense of where do we go from here

Senator MiKULSKl. That's exactly right, and I am trying to look
at, then, if we have only so many dollars, and we want to advance
this, one, of course, would be in the normal processes which would
help every medical student and any health provider — ^but Dr. Pinn,
if we want to really boost

Dr. PiNN. I think in addition to our doing research at NIH, look-
ing at the alternative therapies and their development, I think
what probably does need to be done is to look at the efficacy and
evaluation of outcomes, and I think that really belongs in the
Agency for Health Care Policy. That is where I think the outcome
research should be targeted in addition to what the CDC is doing,
and distribution of use, and for us more the actual research related
to them; but for outcome, I think the Agency for Health Care Policy
would really be the appropriate government agency.

Senator Mikulski. So there is really no one-stop shop in terms
of the new techniques. And then using CDC, the Agency for Health
Care Policy, which does outcomes research which would really be
focused on the surgical procedures, as well as FDA for perhaps
medical

Dr. Pesin. Development of new medications in terms of alter-
native therapies and safety factors.

Senator Mikulski. That would be the place to look at that. But
really, for the surgical techniques, they would be primarily based
in CDC and the Agency for Health Care Policy, with NIH funding
the new pioneering techniques; is that right?

Dr. PiNN. Yes.

Senator Mikulski. Dr. Morley, did you want to comment?

Dr. Morley. There are some regional studies that are very, very
important. I was thinking of agencies when you asked the question
as to a Federal agency available for this. But the Maine study is
a very important study that is being done as a regional area study,
as well as the North Carolina study. There are studies going on
that are regional rather than national that I think are very impor-
tant.

However, it is a long way down the road to get the outcome stud-
ies, and at least we are going in the right direction.

Senator Mikulski. Dr. Morley, I am advised that the Maine
study and I believe also the North Carolina study were funded by
the Federal Government, but done at a regional level So when I
talked about "the place" — I am a great believer in the NIH model
of both intramural and extramural research, and I think really
very few countries in the world follow this extraordinary model of
intramural and extramural — but I think thev did that regionally.

Dr. Morley. That's right. I didn't know all about their funding,
but I do know about their projects.

Senator Mikulski. And Dr. Carlson, who wrote the article that
caught my attention in the New England Journal.

Dr. PiNN. If I could make another comment, I think it is impor-
tant if we are going to look at outcomes while we've got regional
studies; but if you Took, for example, at the differences in the re-
gional use of hysterectomy as well as regional applications of other
perhaps alternative therapies, I think it would become very impor-
tant to try to get national data; just looking at the data on hyster-
ectomy, for example, from the National Center for Health Statistics
and seeing the regionalization and differences, if we really want it
to have an impact and really see what effect we are having right
now, or expected to have, I think it would be very important to
make sure that we are in fact getting national data across the re-

fion, so we don't get just a regional perspective, because we do
now that varies, for example, the South versus the Northeast ver-
sus the Midwest.

Senator Mikulski. Well, of course, we like to know as to why.

I am going to ask one more research question and then go on to
clinical practice and then go on to the next panel, but obviously,
we could have a week-long conference on this subject, and maybe
that is one of the things we ought to think about funding.

Doctor, what additional research would you recommend be fund-
ed if you could very crisply mention

Dr. Pdw. Well, we are doing many things, and the question is
the need to expand and enhance some of the areas that we are
going into

Senator Mikulski. Dr. Pinn, I was asking Dr. Ravnikar.

Dr. Pinn. Oh, okay.

Senator MiKULSKl. You are a doctx)r in the field, like Dr. Morley;
you know what you know, and you know the journals and so on,
and you know what is out there. What, as a clinician as well as
a scholar, would you recommend?

Dr. Ravnikar. Well, sitting back and listening to the part of the
testimony, which was outstanding, I thought — it was really dif-
ferent, anecdotal experiences which really highlight the difficulties
that we as physicians have in clinical practice — to I really appre-
ciate the first panel's testimony, because they made it very succinct
and very clear.

You really have to look at the different disease categories, but for
instance, I as a clinician, treating a woman who is 45, having irreg-
ular bleeding, having fibroids, comes to me after she has been told
by two different physicians that she needs a hysterectomy. Now, I
do do what is called electrocautery of the uterine lining. I have
been trained in it, and I hopefully do it adequately and well, and
she sought me out because I do this procedure. And I went through
a very long preoperative evaluation with her, at which time I had
to tell her that, despite the fact that I thought this was a safe ap-
proach, and indicated in her condition because there was no pathol-
ogy in the uterus, there was no evidence of uterine cancer, I still
had to tell her that we have very few studies in the literature
about this technique, number one, and number two, the studies
that are there tell me that there may be somewhere between a 20
to 60 percent recurrence of bleeding after the technique.

So, after a very well-informed decision, we proceeded with the
technique, and she has done quite well. But I use that as an anec-
dote to tell you that I try to tell patients before they have a proce-
dure, including hysterectomy, all the other options. It does take a
lot of time, but I feel that medical education is very important. But
as I am giving that medical education, because we don't know the
long-term outcome of patients treated perhaps for 4 to 6 years with
LHRH agonist therapy, I have to be honest; the research is not
there.

So I'd love to give you a research protocol, but I think it could
be 2 pages long, because there are a lot of conditions that we do
hysterectomies for which we may be able to develop medical alter-
natives as long as we have the data to substantiate that they pro-
vide safe outcomes.

Senator MiKULSKl. Thank you. I think that's excellent.

Dr. Morley, you might want to add to research, but I am going
to come back to you, the ob-gyn, as a primary care physician. Did
you want to add, though, to the research agenda?

Dr. Morley. I would like to make one quick comment, and that
is that we talk about outcomes studies, and there is another word
I like that is a little more personalized, and that is "quality of life"
studies. Outcomes studies is almost inanimate — which is the same
thing; I think it is semantics. But quality of life is the number one
issue. No longer is it mortality. Mortality is extremely low from
hysterectomy. And yet 150 years ago, the mortality from hyster-
ectomy was 80 percent. That is the mortality of hysterectomy. So
we have come a long way, and I think we have to recognize that
we have done good things.

The other thing is not the research, but the education. Here we
are in Washington, DC. this whole week — I have been here since
last Friday — at the annual clinical meeting of the American College
of Obstetricians and Gynecologists, hearing all this discussion on
rollerball electrocoagulation of the endometrium, on alternatives —
these are all the new alternatives that you are mentioning

Senator MncuLSKi. Rollerball alternatives.

Dr. MoRLEY. — rollerball electrocoagulation — I think Veronica al-
luded to it — and it is a good alternative, but we don't have the re-
sults; 20 to 60 percent of them bleed within 2 years.

So all I am saying is that education is so important; research is
so important; patient care is so important, because that is what we
are dealing with today, and we have to recognize quality of life in
these people as the number one issue. I'm sorry, I got carried away.

Senator Mikulski. No; I think that's well-said.

My question goes, then, not only in terms of research, but within
this year we will have a significant reform of health insurance. And
I have been very clear in the discussion to say that we aren't only
talking about reforming the insurance system, but it will have a
tremendous impact on the delivery system. And the women of the
Senate, on a bipartisan basis, met with the First Lady and talked
about how women should not be grafted on as an addition to some-
thing called the national system, but should be an integral part of
it, and our situation, and those situations unique to us to be con-
sidered. And one of the things that we spoke to the First Lady
about was the fact that we feel, and our experience has been that
the ob-gyn physician is often the primary care physician for
women, and therefore needs to be regarded as that even though
they are specialists, just like internists are also specialists, but
they are now viewed as the primary caregiver.

Having said that. Dr. Morley, I wonder what you would rec-
ommend to us that, as we consider national health insurance re-
form, we should keep in mind to enable a physician like yourself
and all the others who are members of the Academy to have, one,
hassle-free medicine, which I spoke to, and then other aspects that
should be core elements in our thinking and analysis about reform-
ing the health insurance system.

Dr. Morley. When you say "hassle-free," I suspect you are also
talking about malpractice issues

Senator Mikulski. I am happy to listen to anything that can
take the pressure off of you, to enable you to do a good job, and
so that it is focused on the patient.

Dr. Morley. A couple things come to mind. We do defensive
medicine. We do order tests defensively because of the issue, and
I guess I don't want to carry on in that vein.

I do favor, and I think you mentioned it earlier, standardization
of forms. We have so many different forms from so many insurance
companies, so many informed consent analyses. If we could have a
standard form, not necessarily Federally legislated, but medically
legislated, a standard form for informea consent so that we could
taS:e the condition of endometriosis and we'd have all this informa-
tion in-depth — I called it informed information — before they give us
informed consent. I think that is a very important thing. I think

68-667 - 93 - 3

you have to standardize things to try to control some of these costs,
because they are obviously out of control.

And you mentioned in your opening statement unnecessary
hysterectomies. I suspect there are some unindicated
hysterectomies. I think there are some marginal ones where some
people would say yes, that is indicated, and some people would say
no, it isn't indicated. And that is in a gray zone, and it does become
a judgment call. We don't have cookbook guidelines. We have good
guidelines, however, but not that are going to be 100 percent appli-
cable.

The standards of care, for example, that are in the ACOG quality
assurance book on hysterectomy for a variety of indications are
very good; they are guidelines, but they are good standards, and I
support them.

I think the biggest thing we have to realize today is that the con-
stancy of incidence of hysterectomy per year is staying stable, and
I think we all agree to this — in spite of the fact that the population
is going up. So I have the feeling we are doing something good. But
nevertheless, I am not being complacent about it. There are so
many things where I think that the research, the education, and
the peer review is very good. I like second opinion. I think if you
are sure of your judgment on something, you shouldn't be hesitant
about getting a second opinion on something you have rec-
ommended for a patient.

So those are some of the things, and I know they are random
thought, but I am trjdng to cover some of the areas.

Senator Mikulski. Well, Doctor, actually, I turn to you, and I
turn to the college as well, because there are many advocates with-
in both parties and within both the House and the Senate who
really believe that the needs of women need to be address in the
core benefit package. We welcome your advice as to what those core
benefits really are. And second, I am a firm believer in freedom of
choice. I really think that regardless of what modalities and organi-
zations, that you should be able to pick whom you want to talk to.
Those are some of my core elements, as well as reducing the has-
sle— so that we would have this clearly in our minds, and then I'll
come back to an issue about defensive medicine.

Dr. Ravnikar, did you want to comment on that?

Dr. Ravnikar. Yes. Looking at this again from a physician's
standpoint, we aren't necessarily paid to give medical education to
patients. As an example, before a surgical procedure, a pre-op visit
is usually not covered by insurance. I still obviously do that, and
I spend a lot of time with the patient, analyzing her decisionmak-
ing process and stepping back and asking her, "Do you understand
what is going on? Do you understand that you are signing informed
consent?"

And again, I would say that I have no problem with second opin-
ions. In fact, I encourage them even if an insurance company does
not mandate a second opinion, because you truly want to be sure
of a very big decision such as a hysterectomy, and especially taking
out the ovaries.

So I would say that there should be greater insurance reimburse-
ment for medical education of patients.

Senator Mikulski. And pre-op, as you said, because after the ini-
tial decision is made for a surgical procedure that is profound and
irreversible, you feel that — I'm going to use the term "cooling off
period" — where people have had time to reflect and might even
have additional questions, then, for their final decision.

Dr. Ravnikar. That's right.

Senator Mikulski. And I'm sure that as a clinician, vou believe
that the more patients firmly believe in the rightness of their deci-
sion, the more that enhances the success of their decision.

Dr. Ravnikar. Exactly. I agree with that.

Senator MncuLSKi. Dr. Morley, you raised the issue of defensive
medicine, and we are very well aware of that. I wonder if, because
the ACOG guidelines are often tilted in favor of the hysterectomy,
doctors are reluctant to stray fi'om those guidelines and perhaps
take a more broad approach to some of the new techniques, be-
cause they are concerned that the very nature of the guidelines has
an impact on the defensive medicine, and therefore there is per-
haps reluctance to try some of the new modalities. Could you com-
ment on that?

Dr. Morley. Yes, but in introducing that, I would say that I am
excited about the focus on women's health that is going on at the
present time and for the next years to come, and the primary care
issue, because I didn't actually comment on that earlier.

But as far as the guidelines that we use, we have to use guide-
lines that have some oackground to them, some evidence that these
things are the correct ways. We can't use guidelines yet on how to
do tne alternatives to hysterectomy— for example, the GNRH
analogs or the alternatives to hysterectomy as far as abnormal
bleeding — ^because they haven't been tested long enough to know
that that is really the wave of the ftiture. But we are working on
that, and we are discussing it.

One of the examples, however, that is perhaps not in the side-
lines is myomectomy. Myomectomy is a very good alternative to
hysterectomy, and I heard about it this afternoon; there is no ques-
tion about it. There are some concerns about myomectomy because
it is a little more of a morbid procedure — there are a few more com-
plications with it than doing the hysterectomy — and then the
fibroids do return. But by and large, I feel that if a patient wants
to have a myomectomy, I am very much in support, given that I
gfive her the reasons why I prefer, say, a hysterectomy or a
myomectomy. I like to have the opportunity to give them what I
think is the best or better of the choices that I am giving her, and
the reasons why.

Senator Mikulski. Thank you. Dr. Morlev.

There are many other questions we could ask, but we have one
more panel, so we thank each and every one of you again for your
testimony and your openness and your candor.

Dr. Pinn, I would note that there is another institute or office
that has been established on alternative medicine. They don't seem
to have their agenda clear on what they are going to look at in
terms of women, so you might want to give them a call.

Dr. PiNN. Yes. They are working on that, and I spoke to Dr. Ja-
cobs last night, and he pointed out that they have already funded
a study with the National Center for Nursing Research to look at

the postmenopausal woman and factors related to that in terms of
alternative therapies, and they have just issued recently a Request
for Applications across the spectrum, and they are hoping to re-
ceive and are very interested in funding if they receive proposals
to look at alternative therapies related to women's health.

Senator MiKULSKl. Well, thank you. But keep talking to them.

Dr. Finn. So they are in the ball park, and we are going to work
with them.

Senator MncuLSKl. Thank you. Dr. Finn.

We now call our final panel: Dr. Karen Carlson, whose article I
read in the New England Journal; Dr. Widen, Dr. Gambone, and
Dr. Gloria Bachmann.

STATEMENTS OF DR. KAREN CARLSON, DIRECTOR, WOMEN'S
HEALTH UNIT, MASSACHUSETTS GENERAL HOSPITAL; DR.
ARNOLD L. WIDEN, VICE PRESIDENT AND MEDICAL DIREC-
TOR, BLUE CROSS AND BLUE SHIELD OF ILLINOIS, DR. JO-
SEPH GAMBONE, ASSOCIATE PROFESSOR OF OBSTETRICS
AND GYNECOLOGY, SCHOOL OF MEDICINE, UNIVERSITY OF
CALIFORNIA AT LOS ANGELES, AND DR. GLORIA A.
BACHMANN, PROFESSOR AND CHIEF, DIVISION OF OBSTET-
RICS AND GYNECOLOGY, UNIVERSITY OF MEDICINE AND
DENTISTRY OF NEW JERSEY

Dr. Carlson. I am speaking today as an investigator of the
Maine Women's Health Study, a large study of hysterectomy that
was supported by the Agency for Health Care Policy and Research.
I am an internist and director of a multispecialty women's health
unit at Massachusetts General Hospital, and I am a member of the
faculty at the Harvard Medical School.

I am also a primary care physician, and as such, I often treat
and advise women who may need a hysterectomy. In my practice,
I can see first-hand the distress that women experience from condi-
tions which lead to hysterectomy.

Senator Mlkulski. Dr. Carlson, I am going to ask that that
microphone come closer to you. Your article had a big impact, and
I want your voice to be able to do the same.

Dr. Carlson. Thank you.

These conditions are very common, and they can cause a great
deal of disability and limitations in women's lives. I have heard
firom my patients a spectrum of reactions to hysterectomy ranging
from being delighted to feeling that life has changed for the worst.
Finally, I nave seen that my gynecologist colleagues have a range
of different opinions about hysterectomy— some feeling it is very
much overused and others swearing by its effectiveness for improv-
ing quality of life in many patients.

There is a great deal of variability in how frequently hyster-
ectomy is done in different parts of the United States. This vari-
ation is not at all surprising considering how little we know about
the outcomes of hysterectomy.

As I see it. there are three major gaps in our medical knowledge
concerning tne conditions that lead to hysterectomv. The first has
to do with the natural history — that is, the expected course — of con-
ditions such as fibroids and prolapse. Clinical decisions about when
to do a hysterectomy are made based on assumptions that have

never been tested — for example, the assumption that women with
fibroids or prolapse who have few symptoms now should be oper-
ated on anyway, because they will have worse symptoms later or
because delaying surgery will increase its riskiness.

The second gap is in knowledge of the outcomes of hysterectomy
and of other treatments for fibroids, abnormal bleeding, chronic
pelvic pain, and prolapse. There are a number of medical treat-
ments, and some new and less invasive surgical treatments which
can be alternatives to hysterectomy. But we have very little data
on the effects of these treatments on symptoms and quality of life.

Finally, we lack what we need to know to help individual women
make decisions about hysterectomy which are best for them. The
decision to have a hysterectomy is a very personal one; women's at-
titudes and values should have a major role in the decision. Indi-
vidual women vary in how they view hysterectomy, and there are
also major cultural differences in the way hysterectomy is viewed.
Yet we know little about the spectrum of attitudes held by patients
toward sjnnptoms and surgery, and little about how to teach pa-
tients what they need to know to make the best decision.

Efforts are iust beginning to address some of these gaps. The
Maine Women s Healui Study was designed to look at the outcomes
of hysterectomy and nonsurgical treatment for common conditions.
We studied practice in Maine because physicians there have his-
torically been willing to look critically at their own practices. We
focused on the three most common conditions that lead to hyster-
ectomy.

I can share our results with you now in a general way. First, we
found that the conditions which lead to hysterectomy do cause sub-
stantial discomfort and disability. We found that hysterectomy was
very effective for making patients feel better and for improving
their quality of life. Although we had been concerned about long-
term problems such as pelvic pain, depression, and loss of sexual
function after hysterectomy, we found that these problems were
quite uncommon in the year after hysterectomy.

We also looked at nonsurgical treatment that had been in wide
use but not very well-studied. Nonsurgical treatment was also ef-
fective for many patients, and side effects were not very frequent.
However, it did not work well for a substantial number of patients
who had abnormal bleeding or chronic pelvic pain.

Based on the findings of this study, we believe that hysterectomy
can be an effective treatment with a relatively low rate of side ef-
fects. However, nonsurgical treatments can also be effective for
many women. The general policy implications are that conservative
treatment for fibroids, abnormal bleeding and chronic pelvic pain
should be the first step in treatment, with hysterectomy reserved
as a useful alternative for women who do not respond. Our study
did not address the relative cost-effectiveness of different treat-
ments, and it was limited to a largely white population. Since the
cultural context for hysterectomy could be expected to influence the
response to surgery, it is important to examine hysterectomy in
culturally diverse populations.

The Maine Study was just one small step toward addressing the
gaps in research on hysterectomy. The Agency for Health Care Pol-

icy and Research is also supporting a second, expanded study of
hysterectomy outcomes in Maryland.

What should be the directions for future research in this area?

First, I think we need studies on the epidemiology of common
conditions leading to hysterectomy, particularly fibroids and
prolapse, in order to judge which patients can be observed without
treatment and which might benefit from hysterectomies.

Second, we need more information on how to use diagnostic tests
to reduce the need for hysterectomy. And finally, we need more in-
formation on how well alternatives to hysterectomy work and on
the cost-effectiveness of various treatments for these common con-
ditions. This includes both treatments which are in wide use, but
unstudied, such as hormonal therapy for abnormal bleeding, and
newer treatments such as endometrial ablation, which is a less
invasive surgical approach.

It is critically important that we study these new approaches
now, before they become more widely used without adequate eval-
uation.

Last, I would like to say that I think in order to translate the
kind of research that we are doing into changes in clinical practice,
we also need to understand more about women's attitudes toward
hysterectomy and better ways to communicate information to our
patients about their treatment options.

I would like to thank you on behalf of my patients for focusing
your concern on this issue today.

Senator Mikulski. Thank you. Dr. Carlson. Obviously, your arti-
cle has had an impact and I think has stimulated a tremendous
amount of discussion.

[The prepared statement of Dr. Carlson follows:]

Prepared Statement of Karen Carlson

I am speaking today as an investigator of the Maine Women's Health Study, a
large study of hysterectomy supported by the Agency for Health Care Policy and Re-
search. I am an internist and director of a multispecialty women's health unit at
Massachusetts General Hospital in Boston, as well as a member of the faculty at
Harvard Medical School.

As a primary care physician I often treat and advise women who may need a hys-
terectomy. In my practice, I can see first-hand the distress that women experience
from conditions wnich lead to hysterectomy. Ninety percent of hysterectomies are
done for noncancerous conditions such as fibroids, abnormal bleeding, and chronic
pelvic pain. These conditions are very common, and they can cause a lot of disability
and limitations in women's lives. I've heard from my patients a spectrum of reac-
tions to hysterectomy, ranging from being delighted, to feeling that life has been
changed for the worse. Finally, I have seen that gynecologists have very different
opinions about hysterectomy — some feeling it is very much overused, and others
swetiring by its effectiveness for improving quality of life in many patients.

There is a lot of variability in how frequently hysterectomy is done in different
parts of the United States. This variation is not surprising given how little we know
about the outcomes of hysterectomy. It is amazing that although hysterectomy has
been the second most common surgical procedure in this country for the past 20
years, there has never been a study showing its effects for noncancerous conditions
until our Maine study.

There are three major gaps in our medical knowledge concerning conditions that
lead to hysterectomy. The first has to do with the natural history (that is, the ex-
pected course) of conditions such as fibroids and prolapse. Clinical decisions about
when to do a hysterectomy are made based on assumptions that have never been
tested — for example, the assumption that women with fibroids or prolapse who have
few symptoms now should be operated on anyway because they wUl have worse
symptoms later, or because delaying surgery will increase its riskiness.

The second gap is in knowledge of the outcomes of hysterectomy and of other
treatments for fibroids, abnormalbleeding, chronic pelvic pain, and prolapse. There
are a number of medical treatments and some new and less invasive surgical treat-
ments which can be alternatives to hysterectomy. But we have very little data on
the effects of these treatments on symptoms and quality of life.

Finally, we lack what we need to know to help individual women make decisions
about hysterectomy which are best for them. The decision to have a hysterectomy
is a very personal one; women's attitudes and values should have a major role in
the decision. Individual women vary in how they view hysterectomy, and there are
also major cultural differences in the way hysterectomy is viewed. Yet we know lit-
tle about the spectrum of attitudes held by patients toward symptoms and surgery,
and little about how to teach patients what they need to know to make the best
decision.

Efforts are just beginning to address some of these gaps. The Maine Women's
Health Study was designed to look at the outcomes of hysterectomy and nonsurgical
treatment for common conditions. We studied practice in Maine because physicians
there have historically been willing to look critically at their own practices. We fol-
lowed women who had a hysterectomy for any noncancerous condition and women
who were treated without surgery for fibroids, abnormal bleeding, or chronic pelvic
pain — ^the three most common inmcations for hysterectomy.

I can share our results with you in a general way. First, we found that the condi-
tions which lead to hysterectomy do cause substantial discomfort and disability. We
found that hysterectomy was very effective for making patients feel better and for
improving their quality of life. Althou^ we had been concerned about long-term
problems such pelvic pain, depression, and loss of sexual function after hyster-
ectomy, we found that these problems were quite uncommon in the year after hys-
terectomy.

We also looked at nonsurgical treatment (that is, hormonal treatment and other
medications which have been in wide use, thou^ they have not well been well-stud-
ied.) Nonsurgic^ treatment was also effective for many patients, and side effects
were not very frequent. However, it didn't work well for a substantial number of
patients who had abnormal bleeding and chronic pelvic pain.

Bfised on the findings of this study, we believe that hysterectomy can be an effec-
tive treatment with a relatively low rate of side effects. However, nonsurgical treat-
ments can also be effective for many women. The general policy implications are
that conservative treatment for fibroids, abnormal bleeding, and chronic pelvic pain
should be the first step in treatment, with hysterectomy reserved as a useful alter-
native for women who do not respond. Our study did not address the relative cost-
effectiveness of different treatments, and was limited to a largely white population.
Since the cultural context for hysterectomy could be expected to influence the re-
sponse to surgery, it is important to examine hysterectomy in culturaUy diverse pop-
ulation.

The Maine study was just a small step toward addressing the gaps in research
on hysterectomy. The Agency for Health Care Policy and Research is also support-
ing a second, expanded study of hysterectomy outcomes in Maryland.

What should the direction be for research in the future?

First, we need studies on the epidemiology of common conditions leading to hys-
terectomy, particularly fibroids and prolapse. Prolapse is particulfirly an issue for
women as tney age; it s the most common indication for hysterectomy in women over
65. We don't know enough about the expected course of these conditions to judge
which patients can be observed without treatment, and which might benefit from
hysterectomy.

Second, we need more information on how to use diagnostic tests to reduce the
need for hysterectomy. New imaging approaches such as transvtiginal ultrasound
and magnetic resonance imaging can oe used to follow women who may have needed
hysterectomy in the past to rule out cancer, but there are few studies on the effec-
tiveness of these tests to ^ide us.

Finally, we need more information on how well alternatives to hysterectomy work
and on the cost-effectiveness of various treatments for common noncancerous condi-
tions. This includes both treatments which are in wide use, but unstudied, such as
hormonal therapy for abnormal bleeding; and newer treatments such as endometrial
ablation, a less invasive surgical approach for bleeding and fibroids. It is critically
important that we study these new approaches now before they become more widely
used without adequate evaluation. In order to compare different treatments, we
need more research on methods of measuring the key clinical variables so that we
are sure that we compare "apples with apples". Finally, in order to translate the
kind of research I've outlined into changes in clinical practice, we need to under-

stand more about women's attitudes toward hysterectomy, and better ways to com-
municate information about treatment options to patients.

On behalf of my patients, I thank Senator Mikulski and the subcommittee for ad-
dressing our concerns about hysterectomy here today.

Senator Mikulski. Now we'll turn to Dr. Arnold Widen, who is
the vice president and corporate medical director at Blue Cross and
Blue Shield in Illinois.

Dr. Widen, I know that the Blues have done their own study, and
we welcome your testimony.

Dr. Widen. Thanks very much, Senator Mikulski. I really wel-
come the opportunity to speak to you about this very, very impor-
tant issue. Incidentally, I am also an academic, being on the faculty
of Northwestern University Medical School, and I still practice
part-time, and am a Fellow of the American College of Physicians.
I say that only to point out that I think I bring more than an insur-
ance perspective to this issue.

For all the reasons that you have heard today, we thought we
should look at hysterectomy. Hysterectomy is the second most com-
mon operation in the United States, and interestingly enough, the
most common operation in the United States for both sexes is Cae-
sarean section.

Since surgical rates are so high in the United States, since hys-
terectomy rates are so high in the United States, for all the reasons
that you heard so eloquently stated in the first panel, about the
emotional side effects as well as the physical side effects of hyster-
ectomy, which are not as well-understood as we would hope they
would be, for all those reasons, we thought that we ought to look
at our claims experience to see if we could come to some deductions
from those claims experiences that might help us decide regarding
the efficacy and the incidence of this operation.

From the beginning, we decided that we would make this
database and the analysis of this database available to the medical
profession if it might be of help to them, and more importantly, we
decided that we would make it available to women, the general
population of women, because we felt that it may well have been
that our studies would lend credence to the idea that there could
be medical approaches to their problems and less intense surgical
approaches that would resolve their problems without having to re-
sort to hysterectomy.

What we have done essentially are three phases of an ongoing
study which is going on now. This is essentially a claims-based
study, so I want you to understand it is not a scientific study such
as Dr. Carlson and others have done. But I think it is germane.

We first looked at our hysterectomy claims from 1987 through
1989. There were 6,000 such. We divided them into two diagnostic
categories — those which were done for a malignant or cancerous
condition of any type of severity anywhere within the female repro-
ductive system, and those that were benign. Then, we divided the
benign diagnoses into two groups — over age 40 and under age 40.

To make a long story short, we found that 10 percent of the
hysterectomies in this group of women were performed for some
type of malignancy, and we assumed that therefore there was a
justification for doing the hysterectomy as part of the overall treat-
ment of that particular malignancy.

However, in the benign group, 60 percent were over the age of
40, and 30 percent were under the age of 40. And we were very
concerned about that particular statistic, that 30 percent of women
who had had a hysterectomy were under age 40 — and actually, I
have heard higher numbers today, but this was in our experience —
were under age 40, and these were for benign conditions. Now, I
do not mean to imply that they were all unnecessary, but given all
the facts that you have heard today about alternative treatments,
and given the fact that surgical rates are so high, and hyster-
ectomy rates are so high, and there are other alternative hormonal
treatments, there are other alternative surgical treatments which
are much less invasive, we came to the deduction that perhaps one-
third of all hysterectomies might have been avoided. Now, we
couldn't prove that, but that was a deduction that we made based
upon this claims analysis.

We shared this with the media because we felt we ought to bring
this possibility to the attention of women so that they could appro-
priately question their physicians about the need for the hyster-
ectomy in their particular case.

Well, we continued that analysis later on for the years 1990 and
1991, and again, to make a long story short, the claims analysis
showed the same thing — 90 percent were benign, and of those, 30
percent were under age 40.

Then we looked at the incidence of hysterectomies per hospital
in the State of Illinois. And of course, big hospitals will do more,
but we also found that there was a tremendous variation among
hospitals of similar size in the incidence of hysterectomies for be-
nign conditions for women under age 40.

Well, now what we have done in our most recent phase is a little
more, if you will, clinical. What we did was to write to all the hos-
pitals and ask them to randomly select 33 percent of the charts of
their cases of women imder age 40 who had had a hysterectomy for
benign diagnosis. We then looked at those cases against previously
published standards. These standards have been published by an
organization that does work in publishing standards based upon re-
view of the literature and based upon expert panel work for decid-
ing regarding the appropriateness of procedures. They were first
reviewed by a nurse reviewer, then by a physician reviewer. A
number of cases, you could not come to any decision, and we threw
those out of the analysis, because we wanted to lean over back-
wards to be fair.

Again, to make a long story short, in one-third of the cases of
hysterectomy that we reviewed in women under the age of 40 for
benign condition, it was felt that these cases did not meet appro-
priateness criteria and that therefore they were medically imneces-
sary.

The human cost of this, you have already heard about, and that
by far is the most important. But there are significant financial im-
plications. In 1991, our average cost from the hospital for a hyster-
ectomy was $7,600, and that is exclusive of any professional fees;
with tne professional fees and the escalation, you are probably talk-
ing more about $11,000 or $12,000. But that is such second.ary to
the human cost that you have already heard about.

I have it in my testimony, but I want to publicly give a kudo to
the article, "Current Concepts: Indications for Hysterectomy," that
was in the March 25, 1993 issue of the New England Journal of
Medicine, by Drs. Carlson, Nichols, and SchiflF. I believe that if ob-
gyns followed the guidelines in that article, we would see a very
significant reduction in the incidence of hysterectomjyr.

My last point. Senator Mikulski, is that we dont think hyster-
ectomy is an isolated problem in American medicine. If you look at
the American medical literature, you will see that there have been
many articles in all kinds of specialties raising the issue regarding
the appropriateness of medical therapy, especially about the appro-

Eriateness of performing many procedures; questions have even
een raised about doing x-rays of all types, MRIs, the appropriate-
ness of doing angioplasty, and so on. And these articles will vary
all over the place, but in some of these articles, the C-section rate,
for example, in the United States is aroimd 25 percent. I don't
know what the ideal rate is, but in many academic centers, in
many articles, the rate of 15 percent has been achieved. That
would be a 40 percent reduction.

We feel that if you look over this literature, you can make a rath-
er conservative estimate that out of the total $900 billion that we
are currently spending on medical treatment in the United States,
that somewhere over $100 billion of it is on unnecessary medical
treatment.

My last pitch is about utilization management. It is a hassle for
physicians. I would like to see utilization management replaced by
practice protocols, and we are involved in doing that, but that is
a long-term goal. In the meantime, we are concerned that we do
need to carry on utilization management because, if properly done,
utilization management eliminates unnecessary procedures that ac-
count for this $100 billion, because by definition, if we are doing
an unnecessary procedures, we are doing something that will not
improve health outcomes, but yet has subject the patient to risk
and complications and therefore should be

Senator Mikulski. Dr. Widen, those bells are ringing to tell me
that in about 20 minutes I am going to have to move to a different
place in the Senate and be prepared to vote. So could you conclude?

Dr. Widen. I have one last sentence, and that is my sincere hope
that the health care reform legislation will include mechanisms
that will encourage the reduction of unnecessary services and save
our Nation enormous amounts of money and, more importantly, re-
duce human suffering.

Thank you so much.

Senator Mikulski. Thank you.

[The prepared statement of Dr. Widen follows:]

Prepared Statement of Arnold L. Widen

Mv name is Arnold L. Widen, M.D. I am the Vice President and Corporate Medi-
cal Director of Blue Cross and Blue Shield of Illinois. I am also an Associate Profes-
sor of Medicine at Northwestern University Medical School, a Fellow of the Amer-
ican College of Physicians, a member of the Board of Governors of the Institute of
Medicine of Chicago, and I continue to practice on a very part-time basis.

I want to sincerely thank this committee for the opportunity to talk to you about
this important medical issue.

HyBterectomy is the second most common operation performed in the United
States, including both sexes. Interestingly enough, the most conmion operation in-

eluding both sexes is Caesarean section. Since overall surgical rates are so high in
the United States, since hysterectomy is so common, and since significant questions
have been raised by many medical authorities about the indication for performing
a hysterectomy, as well as about the possible occurrence of some poorly under8too<^
undesirable physical and even emotional side effects of hysterectomy, Blue Cross
and Blue Shield of Illinois decided toperform studies which might give us a better
understanding of the incidence and efficacy of this procedure. From the onset, it was
our intent to then communicate our data, and any deductions we reached based on
an analysis of our data, to both physicians and the general population of women;
it was our hope that such studies would be helpful in the medical debate about the
appropriateness of hysterectomy, but, more importantly, might bring to women's at-
tention the fact that often their symptoms could be resolved by medical approaches
and/or less extensive surgical procedures, without resorting to hysterectomy.

Essentially, Blue Cross and Blue Shield of Illinois has now performed 3 phases
of an ongoing hysterectomy study. We first did an analysis of 6,000 hospital claims
submitted to Blue Cross and Blue Shield of Illinois for the performance of a hyster-
ectomy during a 3-year period, 1987 through 1989. We divided all of the diagnoses
that were usm to justify the hysterectomy into two groups: (1) a malignant or can-
cerous disease of any degree oi severity located anywhere within the female repro-
ductive system, and (2) all other conditions, which by definition, were benign or
noncancerous problems, it was our assumption that whenever a malignant condition
was present, a hysterectomy as part of the overall treatment approach, was prob-
ably justified. We then divided the benign cases into two groups based on age —
those women under age 40, who were, therefore, still in the prime child-bearing pe-
riod of their lives, and those women aged 40 and over, albeit that many women over
age 40 can have an uncomplicated and successful pregnancy. We found that only
8.8 percent, or about 10 percent, of this large group of hysterectomies, were per-
formed because of some sort of malignant condition; furthermore, of the 90 percent
of cases in which the diagnosis was of a benign condition, 60.1 percent were of
women over age 40, and 30.1 percent were of women under age 40. To us, the im-
portant statistic was that 30 percent of these hysterectomies were performed on
women in the prime child-bearing period of life, for benign conditions. By no means,
did we imply that all these hysterectomies were not indicated, but given the pres-
ence of otner effective treatments, and given the very hirfi rate of hysterectomy in
the United States, we deduced that perhaps one-third of all hysterectomies were un-
necessary. We did share this data with the media, not in the interests of sensa-
tionalism, but rather to encourage the general population of women to consider al-
ternatives to hysterectomy, and to carefully question their physicians about the indi-
cations for the procedure In their particular case.

We next penormed an analysis, based on data derived from one of our large
claims databases, of hyaterectomies performed in 1990 and 1991. We again deter-
mined the percentages of malignant versus nonmalignant diagnoses, and the age
distribution of women who had a hysterectomy; however, we also determined the
incidence of hysterectomy, broken down by these diagnostic and age categories, for
every hospital in the State of Dlinois from which we had received a claim for the
performance of a hysterectomy. Once again, we found that approximately 91 percent
of hysterectomies were for benign conmtions; in 1990, 30.3 percent of these women
were under age 40, and in 1981, 30.8 percent were under age 40. About 46.5 percent
of all hysterectomies were performed on women between the ages of 40 and 49. Ob-
viously, more hysterectomies were performed at lareer hospitals, but we did note
great variation in the number of hysterectomies performed for benign conditions in
women under the age of 40 even among hospitals of similar size.

We continued this analysis of the occurrence of hystorectomies, broken down into
age and diagnostic categories, per hospital, in 1992. However, of more importance
was the fact that in 1992 we wrote to the hospitals asking them to send us copies
of the medical records of a randomly selected sample of approximately 33 perctnt
of the cases in which a hysterectomy was performed on a woman between the ages
of 20 and 40, for a benign condition. These records were reviewed using an abstrac-
tion form, and appropriateness criteria, that have been published by an organization
that has developed such criteria for determining the appropriateness of the perform-
ance of a large number of procedures. This organization's criteria are generally con-
sidered to be legitimate and conservative by managed care organizations. We re-
ceived 114 charts from the hospitals. These cases were first evaluated for the appro-
priateness of the procedure, using the written standards, by a nurse reviewer; all
cases in which it was decided that the hysterectomy was inappropriate, were re-
evaluated, again against the standards, by a physician reviewer. A certain number
of chfirts were felt to lack adequate documentation to permit the physician reviewer
to make a legitimate decision as to the appropriateness of the hysterectomy. How-

ever, even when such cases were eliminated from the review process, and after eval-
uation against written standards by both the nurse and physician reviewers, it was
deemed Qiat 33 percent of these hysterectomies performed in young women for be-
nign conditions were medically unnecessary, or inappropriate. Of course, the human
cost of an unnecessary hysterectomy is our most important consideration, but there
are also very significant financial implications, since in 1991, the average hospital
billing to Blue Cross and Blue Shield of Illinois for a hysterectomy was approxi-
matefy $7,600. That cost did not include physicians' fees, and, of course, these costs
are much higher today. We feel that this most recent phase of our hysterectomy
study lends credence to our original estimate that one-third of all hysterectomies
could be avoided. ,,,,.. - . ,

In the March 25, 1993 issue of "The New England Journal of Medicine , an article
entitled "Current Concepts: Indications for Hysterectomy was published; the authors
were Drs. Carlson, Nichols, and Schiff from the Massachusetts General Hospital ad
Harvard Medical School. This is a superb publication, and I am convinced that if
the guidelines indicated by that article were followed, there would be a significant
reduction in the number of hysterectomies, again perhaps by a third.

However, hysterectomies are only one example of the excessive utilization of
health care services in the United States. There have been estimates pertaining to
many specialties that a laive percentage of procedures and services, even up to one-
third, could be avoided without negative health consequences for patients. If one ex-
tends such deductions to the entire health care system of the United States, it could
be estimated that well over $100 billion of our country's total health care cost of
$900 billion could be saved, and this saving would be enough to finance most of the
health insurance for the 37 million uninsured people in our Nation.

Critics of utilization management claim that utilization control will inevitably re-
duce the quality of health care services. On the contrary, I strongly believe that uti-
lization management improves the overall quality of health care, since such pro-
grams are designed to eliminate unnecessary services. It must be remembered oat
all health care services cany some risk; in general, the risk is justified by the im-
proved health status that it is anticipated will result from the health care interven-
tion. However, if the service is medically unnecessary, then, by definition, it will not
result in improved health outcomes. Therefore, unnecessary procedures subject peo-
ple to risk, to adverse reactions and complications, and even to possible death, with-
out any hope of really improving their health; elimination of such unnecessary inter-
ventions thus improves the heaRh status of a population.

It is my hope that health care reform legislation that may be proposed in the near
future will include mechanisms that will encourage the reduction of unnecessary
services, thereby saving our Nation enormous sums of money, and reducing the
human suffering and loss caused by such inappropriate approaches.

Senator Mikulski. Dr. Gambone, we want to return to you and
Dr. Bachmann and leave some time for questions. We have actually
been fortunate; usually, I am running back and forth with votes,
and the hearings are disrupted. But we have had this great block
of time, and I would like to be able to conclude it before I have to
leave.

So, Dr. Gambone, would you please proceed with your testimony.

Dr. Gambone. Yes. Thank you. Senator Mikulski.

It is well-documented that hysterectomy is among the most com-
monly performed major surgical procedures in the United States.
International variation in hysterectomy rates, along with both re-
gional and small area variation within the United States, strongly
suggest that factors other than medical necessary may determme
whether a hysterectomy is performed or not.

My colleagues, Dr. Robert Reiter of the University of Iowa Col-
lege of Medicine, and Dr. Joel Lench of San Diego, CA, and I have
been studying the indications for hysterectomy and the decision-
making process in elective health care choices for over 10 years
now. We believe that understanding and improving the decision-
maldng process for a largely elective procedure such as hyster-
ectomy, is fundamental to improving the quality of health care, to
cost containment, and indeed, to health care reform. We also be-

lieve that hysterectomy is not unique in this regard and that all
high-consequence elective health care procedures deserve equally
careful scrutiny.

In 1984, we began a quality improvement initiative for hyster-
ectomy at a large teaching hospital in San Diego, CA. This program
involved first standardizing the indications for hysterectomy and
then establishing by consensus of the local medical staff, practice
guidelines or criteria to be met prior to performing hysterectomy
for a given indication.

Rates of compliance with these guidelines were then regularly
fed back to the medical and surgical staff. This intervention re-
sulted in a 24 percent reduction in the utilization of hysterectomy
and significant improvement in diagnostic accuracy which were
sustained for a 4-year study interval. At that time, we believed
that providers alone could control excessive utilization of a proce-
dure such as hysterectomy.

During this same progn^am, we noted that the largest single re-
duction in hysterectomy by preoperative diagnosis was for chronic
pelvic pain. A 70 percent reduction in the rate of hysterectomy for
this indication occurred when patients were provided nonsurgical
alternatives combined with a structured learning program review-
ing effectiveness, risks, and costs associated with hysterectomy.

As part of this consumer-directed intervention program, we de-
veloped a pre-procedural decision checklist using the acronym,
PREPARED, where "F' stands for the procedure that is rec-
ommended; "R" for the reason or indication for doing the procedure;
"E" for the expectation expressed in terms of the patient's needs;
the second "P" for the probability that this expectation will occur;
"A" for reasonable alternatives; the second "R" for known risks of
the procedures; the second "E" for the expenses involved; and the
"D" for the decision that the patient and provider should make to-
gether.

The PREPARED protocol ensures that patients receive all critical
categories of information necessary to make appropriate choices
and simultaneously increases their sense of control over the deci-
sion. Consumer-based interventions, such as standardized pre-pro-
cedural analysis, could significantly reduce inappropriate health
care utilization and associated costs by reducing inappropriate de-
mand for ineffective or inefficient procedures. Furthermore, stand-
ardization of the decisionmaking process should substantially re-
duce medico-legal liability.

Hysterectomy, like many other elective health care procedures, is
overutilized in the United, States for several reasons. First, uncer-
tainty about which procedures work best and insufficient knowl-
edge about their outcome.

Second, insufficient knowledge about the pathophysiology of
many medical conditions. For example, we know very little about
bleeding disorders during the peri-menopausal time in a woman's
life, ages 42 to 50, a time when the highest rate of hysterectomy
occurs.

Third, the overuse of effective, but highly inefficient, procedures
such as hysterectomy for bleeding disorders or harmless conditions
such as uterine fibroids, when medical therapy or even "watchful

waiting" would serve the patient best in terms of minimizing risk
and cost.

Finally, and most importantly, patients and their physicians are
not involved in a collaborative aecisionmaking process which clear-
ly defines a patient's expectation of outcome and ensures that all
reasonable alternatives, all known risks, and all the expenses of
elective procedures like hysterectomy are always discussed prior to
jointly making the decision to perform them or not.

Thank you. Senator.

Senator MnoJLSKi. Thank you, Dr. Gambone. You and Dr. Reiter
and Dr. Lench's study is really pioneering, and certainly adds to
the Carlson work.

[The prepared statement of Dr. Gambone follows:]

Prepared Statement of Joseph C. Gambone
introduction

Very few medical or surgical procedures are associated with as much controvert
as hysterectomy. Hysterectomy is performed about 600,000 times per year in U.S.
hospitals. Since 1981 hysterectomy has been the second most common maior inpa-
tient surgical procedure performed in the United States, and surpassed only by Ce-
sarean delivery. [1,2] There is considerable variation in the rate of hysterectomy,
which is attributable to multiple geographic, patient-and-physician variables. There
is also considerable variation in costs for hysterectomy. [3]

Determining the frequency of utilization of hysterectomy is far easier than deter-
mining the appropriateness of the procedure for various mdications. This task has
been confounded by: 1) lack of agreement as to which hysterectomies are "medically
necessary; [4] 2) lack of standardization of indications for hysterectomy which would
allow comparative analysis of outcomes and utilization; [5] 3) a virtual absence of
reliable outcomes data for hysterectomy and in particular, oatient-related outcomes
such as health status and quaUty of life before and after Hysterectomy; 4) lack of
information about the outcomes of reasonable alternatives to hysterectomy which
may be less risky and less expensive, and therefore, more efficient; and, 5) a lack
of incentive to systematically assess these outcomes.

These concerns are particularly relevant at the present time when clinicians in-
volved in the care of women are attemptinc to assess newer surgical technioues,
such as LAVH, (Laparoscopically Assisted Vaginal Hysterectomy). Although these
procedures are being recommended on the basis of cost-effectiveness and reduced
risk, like "classical" hysterectomy, they are only efficient if the sur^eiy is performed
for appropriate indications, after non surgical alterations have failed. Fortunately,
there are several large studies now underway that are designed to assess many im-
portant clinical and psycho-social outcomes of hysterectomy.

The controversy that surrounds hysterectomy may in part reflect the very wide
spectrum of clinical indications for the procedure. Hysterectomy may be life-saving
when performed in some emergency situations such as intractable post partum hem-
orrhage or when performed to remove uterine cancer. At the opposite extreme, some
hysterectomies are performed for purely elective indications such as sterilization or
cancer prophylaxis.

The electivity" of hysterectomy in clinical practice can be estimated by separating
those indications in which hysterectomy is the only reasonable choice from those in
which hysterectomy is one of two or more alternatives for the treatment of various
gynecologic conditions. Table 1 is an estimate of this distribution from a database
of 1,032 liysterectomies. In this series, hysterectomy could be considered the only
reasonable and available alternative in as few as 5 percent and no more than 17
percent of cases. Therefore, between 83 percent to 95 percent of cases were consid-
ered elective because they involved at least one other reasonable therapeutic option.
The higher the degree of "electivity" of a given indication, the greater the need for
increased patient collaboration and control in the decision to perform the procedure.

II. VARIATION IN HYSTERECTOMY RATES

The measurement of variation in rates of performance and outcomes of health
care procedures has been shown to be a valid method to assess the likelihood of in-
appropriate utilization of technology and is an index of quality of care. Some vari-
ation, of course, can be related to differences in patient characteristics. Table 2

shows large variation in a number of health care procedures after differences in pa-
tients have been accounted for. These findings support the notion that treatment
and outcome differences are more likely to be due to provider variables, rather than
differences between patient populations.

There is a substantial variation in hysterectomy rate according to geographic loca-
tion, patient-related characteristics and physician-related factors. [6] Ine rate can
vaiy £18 much as six fold among Western countries and is highest in North America,
and lowest in England, Norway, and Sweden. [7]

The variation between the United States and Sweden with respect to the likeli-
hood that a women will have had a hysterectomy by the age of 60 is shown in Table
5. This magnitude of variation in relative risk for hysterectomy cannot be explained
by differences in patient characteristics. Hysterectomy rates vary within the United
States with the highest found in the Soutn and West and the lowest in the North-
east. There is also significant variation between small areas within States (see
Table 3). One study showed higher rates of hysterectomy performed by male gyne-
cologists and higher rates of hysterectomy performed on blacks. [8,9] There is also
considerable variation in the costs of hysterectomy within the United States. [10]
These variations, along with the need to increase efficiency in health care, have led
to increased scrutiny of the appropriateness of hysterectomy and recognition of the
need to measure clinical outcomes associated with it.

In 1984 Roos investigated whether the practice style of primary care physicians
influenced utilization of hysterectomy. His methodology controlled tor such variables
as area of residence and previous gynecologic history. [11] Table 4 shows the percent
of physicians by specialty who were likely to recommend hysterectomy to their pa-
tients. His analysis reinforced the conclusion that physician decision-making behav-
ior varies markedly in the face of similar (medical) evidence and variations in such
decision-making may lead to variations in elective surgical rates. Of course, dif-
ferences in utiUzation of hysterectomy do not identify which rate is more "appro-
priate." TTiis determination should be based upon comparative outcomes.

in. THE EVOLUTION OF A QUALITY IMPROVEMENT PROGRAM FOR EVALUATING

OUTCOMES OF HYSTERECTOMY

Reported variation in the utilization of hysterectomy prompted us to establish a
criteria-based quality improvement program for hysterectomy at a large teaching
hospital." We noted that the percentage of hysterectomies performed for chronic pel-
vic pain at this institution was 19 percent of the total indications compared with
12 percent at other institutions reported in a large collaborative study. We specu-
lated that one of the reasons for this high rate was a lack of reasonable alternatives
for this diagnosis. For this reason we established a quality improvement program
for hysterectomy which involved the following methods.

First, a standardized list of indications for abdominal or vaginal hysterectomy was
developed after an extensive literature review (Table 6).

Second, after developing this standardized list, we determined that some of the
indications for hysterectomy could be "verified" by expected histopathology while
other indications could not be confirmed in this way since no tissue pathology was
expected (e.g. uterine prolapse). For these kinds of indications, a system of 'Valida-
tion" using criteria-sets was developed. Criteria-sets may include specific historical
facts or cfinical findings, or certain tests or procedures that the literature estab-
lished should be performed prior to resorting to hysterectomy. These proposed cri-
teria-sets were then reviewed and approved by consensus of the medical staff mem-
bers.

Table 6 lists the standardized indications and the validation criteria for those in-
dications in which normal tissue was expected. More detailed criteria-sets for many
indications for hysterectomy have recently been developed. Validation was accom-
plished by review of the preoperative note which was expected to document that the
criteria had been met prior to the performance of the hysterectomy. Those indica-
tions which were expected to be verified histologically were confirmed by review of
the pathological report. Information about compfiance with this system and rates of
confirmation were "fed-back" to members of the staff on a regular basis.

Third, one and only one indication could be listed preoperatively for the purposes
of confirming the indication for the hysterectomy. This rule was established because
of the suspicion, based upon retrospective review, that the listing of multiple indica-
tions was more likely to occur for those hysterectomies which were less justified. Re-
cently, this suspicion has been confirmed in a study involving another institution
which compared hysterectomies performed when one indication was listed with
hysterectomies performed when multiple indications were listed. [12] Statistically
significant differences in "confirmation ratings" (compliance with criteria sets plus

histologic verification) were observed which suggested that listing of multiple indica-
tions was highly predictive of decreased appropriateness of hysterectomy.

Table 7 is an "^dications profile" of the first 584 consecutive hysterectomies and
shows the total number, percent of total, and the number and percent verified or
validated (confirmed) for each indication. It is noteworthy that the percent of the
total hysterectomies done for chronic pelvic pain had decreased to 6 from 19 percent
of the total performed. This change was attributed to a combination of the "sentinel"
(observer) effect and the establishment of a pelvic pain clinic which provided an al-
ternative to hysterectomy. [13,14] (Details about the clinic and outcomes of this
intervention have been reported.) [15] Additional findings from this initial review
of the hysterectomy "indications profile" were that 93 percent of those indications
which were histologically verifiable (34 percent of cases) were confirmed, and 98 per-
cent of those indications which were potentially "validatable" (66 percent of the total
cases) were confirmed. [11]

After the quality improvement program was initiated, regular feedback regarding
the rates of verification and validation of preoperative diagnoses was provided to
medical staff members. This information was updated every 6 months and aggre-
gated results were made available at weekly preoperative conferences.

In order to compare the overall rate of hysterectomy before and aft«r the quality
improvement program, the charts of all patients who underwent hysterectomy at
the study hospitaQ for a period of approximately 3 years before the program were
reviewed. [16] The listed indication(s) for each hysterectomy was determined. Dur-
ing this control period there was no designated list from which a specific indication
for each hysterectomy could be selected. In those instances where more than one
indication was listed, the first indication was assumed to be the primary one.
Hysterectomies with multiple indications accounted for 92 (14 percent) of the 657
hysterectomies performed during this control period.

The number of hysterectomies performed in each year of the study and control
periods and the number of admissions to the gynecology service for the same years
were tabulated. The rate of hysterectomy was expressed as the rate per 100 gyne-
cology admissions. Review of admission policy, age, race, and other patient charac-
teristics during both periods revealed no factors that might have caused significant
differences between control and study groups in the demographic profile of patients
admitted to the gynecology service. Also, the number of health care providers as
well as the number of available operating rooms was unchanged during both peri-
ods. Prior to implementation of the quality improvement program, operating sur-
geons were unaware of plans for the intervention.

Table 8 shows the results of the comparison before and after the initiation of the
Quality improvement process. A total of 657 hysterectomies were performed during
Uie control period and 748 were performed after the quality improvement program
was initiated. The average quarterly admission rate for the 30-month control period
did not differ significantly from that of the 48-month study period.

A significant (24%) reduction (p<0.001) in the overall hysterectomy rate was ob-
served during the study period. Significant decreases in the rates of hysterectomy
for chronic pelvic pain (p<0.(X)01), recurrent abnormal uterine bleeding (p<0.001),
pre-invasive disease of the uterus (p<0.005), and severe infection (p<0.025) were ob-
served after the quality improvement program was initiated. Adenomyosis was the
only indication for which a statistically significant increase in the hysterectomy rate
was observed (p<0.001).

AAer the quality improvement program was initiated, a significant decrease in
the hysterectomy rate was seen for those indications where pathologic tissue was
not expected (6.5 vs 3.5 per 100 gynecology admissions p<0.001). This group of indi-
cations consisted of pregnancy catastrophe, operative complication, chronic pelvic
pain, stress urinary incontinence, recurrent uterine bleeding, and elective
hysterectomies done for "extenuating circumstances". Also observed was a signifi-
cantly higher percentage of confirmation of "verifiable indications" (abnormal tissue)
after the initiation of the program (82% vs 93%, p<0.001).

Regression smalyses of quarterly hysterectomy rates before and after initiation of
the quality improvement program are shown in Figure 1. Time series analysis of
the rates indicates no significant upward or downward trend within either the con-
trol period or the study period even though the overall rate of hysterectomy was sig-
nificantly lower during the entire study period (10.3 per 100 admissions) than dur-
ing the entire control period (13.5 per 100 admissions). These data suggested that
the observed decrease in overall hysterectomy rate was the result of the quality im-
provement intervention rather than the result of a gradual downward trend in hys-
terectomy rates over time.

The quality improvement initiative described above was primarily focused on phy-
siciem (provider) oehavior. The major components of the intervention (standeiraiza-

tion of indications, consensus-derived criteria sets, and audit and feedback of con-
firmation rates) was directed at increasing the awareness among physician staff of
more or less traditional short-term quality indicators such as histopathologic con-
firmation of the preoperative diagnosis. Interestingly the largest decrease in hyster-
ectomy rate by indication was for chronic pelvic pain (D-1), which was the one pre-
operative diagnosis which also involved a patient intervention. All patients who
would otherwise have been offered a hysterectomy for chronic pain were first re-
ferred to a multidisciplinary pelvic pain clinic. In this setting, appropriate patient
expectations were developed and risks and costs of hysterectomy were reviewed, and
other surgical and nonsurgical alternatives were offered. This experience led to the
development of a preoperative "checklist" which ensured that critical categories of
information were presented before proceeding with hysterec^my. This process was
referred to as standardized pre-procedural analysis. The checklist was designed to
optimize patient involvement (collaboration) in the decision-making process, which
had been shown in other studies to be an important predictor of patient satisfaction.
One of the most important aspects of consumer-based interventions suchi as stand-
ardized pre-procedural analysis, is that they define success in terms of meeting the
patientls expectations of outcome (benefit), rather than the providers' expectations
(e.g., histological verification). This contrast is the basis of the evolution from tradi-
tional "quality assurance" to newer "clinical outcomes" models of assessing health
care quality.

IV. TRADITIONAL VS BEHAVIORAL OUTCOMES OF HYSTERECTOMY

Until recently, medical outcomes research and technology assessment ha? focused
upon assessment of short-term risk. With hysterectomy, as with most health care
procedures, this was usually limited to quantification of mortality and major mor-
bidity, such as infection, blood transfusion aad reoperation, that occurred during the
course of a hospitalization. Most standardized lists of clinical quality improvement
indicators, such as those published by the American College of Obstetricians and
Gynecologists, reflect this orientation.

While the importance of these endpoints in the assessment of the quality of health
care including hysterectomy is obvious, recent research suggests they havp little, if
any, relevance to the far more fundamental question of the success, or eflectiveness,
of hesdth care procedures. For example, if a patient undergoes a hysterectomy for
pelvic pain and experiences no short-term complications, the surgery will be consid-
ered "successful" from the standpoint of risk management and snort-term outcome,
since no quality indicators are present. However, if the patient continues to experi-
ence pain and has no improvement in the quality of her life, the surgery is, in re-
ality, unsuccessful. In other words, short-term risk indicators may have little or no
bearing on whether the procedure actually works.

Previous efforts to measure the success, or effectiveness, of health care procedures
in the United States (including our own intervention described above) were based
on the traditional medical model. Typically in this model, a patient is evaluated for
a symptom, is given a diagnosis, and undergoes treatment for that diagnosis. A pro-
cedure is defined as a success if the diagnosis is confirmed. For example, if a patient
evaluated for pelvic pain is discovered to have a uterine leiomyomata, undergoes
hysterectomy, and fibroids are confirmed histologically, the procedure is considered
successful. This approach is manifest in surgical case review or "tissue" committees
whose purpose is to monitor confirmation of preoperative diagnoses.

Unfortunately, there are several assumptions inherent in the traditional medical
model of clinical outcomes that are frequently incorrect and that have Umited its
usefulness as a basis for evaluation of effectiveness. These include the ass^'roption
that 1) the symptoms are significantly affecting the quabty of the patient's life; 2)
the diagnosis is the cause of the symptoms; 3) treatment of the diagnosis will elimi-
nate the symptoms; and 4) the treatment will not cause significant harm.

If, for example, in the case cited above the patient's pain was minimal, responsive
to nonnarcotic analgesics, and not adversely affecting her life, major surgerj' would
hardly seem appropriate or "successful". Smularly, u her pain v/as actually due to
chronic irritable bowel syndrome, hysterectomy would not improve her symptoms.
The surgery is ineffective, even though there were no short-term complications and
incidental leiomyomata were confirmed histologically. Finally, if the patient experi-
enced chronic dyspareunia following hysterectomy, the harm causea by the proce-
dure may be greater than the harm treated. The only way to evaluate the effective-
ness of the procedure is through longitudinal assessment of the symptoms and the
"harm" for which the patient presented in the first place and the long-term impact
of the procedure on her quality of life.

This latter approach may be termed the "behavioral" model of clinical outcomes.
[17] In this model, "symptoms" are replaced by the more generic concept of "harm",
which may include pain and suffering; loss of function, deformity, or premature
death. Each of these types of harm may be thought of as adverse affects on the qual-
ity or quantity of a patient's life. Table 9 lists examples of behavioral endpoints for
health-related auaHty of life. Long-term success, or effectiveness, of health care pro-
cedures is based on their ability to reverse or prevent harm; that is, on their ability
to improve the quality or quantity of a patient's life. Current trends in outcomes
research are based on the very compelling argument that behavioral outcomes i.e.
quality of life and life expectancy £u« the only relevant measures of the long-term
effectiveness of health care.

It is worth considering the differences in these concepts of quality in terms of
whose expectations Uiey seek to satisfy. As noted above, in the medical model of
clinical outcomes, quality is largely equated with fulfillment of the provider's expec-
tation, i.e. confirmation of tJie diagnosis. By contrast, in the behavioral model of
clinical outcomes, quality is more concemea with fulfillment of the patient's (cus-
tomer's) expectation.

Among the many reasons that medicine has traditionally relied on standards such
as short-t' ^m risk indicators and histologic confirmation is the fact that these are
relatively cLjective and quantifiable. Death and infection rates, blood loss, and rates
of histologic verification can all be measured, expressed numerically, and to an ex-
tent, reproduced with some degree of reliability. As Kaplan has stated, this need
to measure "precisely^ is best summed up as the "curse of Kelvin"; that is, just be-
cause something can be measured does not mean that it is useful to do so. [18] Cru-
cial to the appucation of the 'Taehavioral" model of clinical outcomes would be sci-
entifically valid and reliable methodology to measure health-related quality of life.
Ironically, hundreds of such measures nave been developed and validated, few of
which have found their way into clinical practice or clinical research. Routine utili-
zation of these measures to evaluate whether we are meeting our patients' expecta-
tions will provide the ultimate standard by which to evaluate the "appropriateness"
or effectiveness of health care procedures including hysterectomy.

V. DEX:iSION-MAKING AND STANDARDIZED PRE-PROCEDURAL ANALYSIS

Involving the patient in the decision-making process is fundamental to the task
of defining appropriate patient expectations for health care procedures. Recent re-
search, however, nas indicated that patients are reluctant to assert themselves in
health care settings. A variety of explanations have been provided for this phenome-
non. Current behavioral research suggests that appropriate decision-making re-
quires two basic ingredients, namely, accurate information (outcome expectation),
and the ability to choose (self-efiicacy). Figure 2 is a theoretical representation of

ftatient status when it comes to health care decision-making. As can be seen at the
ar left of the figure, some patients are characterized as having complete autonomy.
They view themselves as purchasers of services and they take a leading role in dis-
cussions, asking questions, introducing topics, expressing opinions, and determining
clinical decisions. In terms of decision-making, these patients will be characterized
as having high self-eflicacy, and wiU usually acquire sufficient information to de-
velop appropriate expectations of outcome.

At the other extreme is the patient who abdicates her role in decision-making.
This kind of patient is often passive and therefore may be reluctant to ask questions
or even express opinions. These patients would be characterized as having low self-
eflicacy; in addition, they may be very susceptible to a phenomenon known as de-
mand effect, which is the desire on the part of the patient to conform to the per-
ceived wishes of the physician. In health care decision-making, when there is pa-
tient abc^cation, the provider does most of the talking, asks most of the questions,
chooses the topics for discussion and frequently interrupts the patient. [19,20] Some
researchers point out that patient abdication is occasionally unavoidable, as when
emergency treatment is needed or when treatment alternatives do not exist. [21] As
indicated earlier, this occurs only about 5 percent to 17 percent of the time with
hysterectomy.

In the center of the figure is the theoretical ideal situation, that of collaboration.
For this kind of health care decision-making, the health care provider and patient
work together to reach an appropriate decision. It has been shown recently that col-
laboration can only occur wnen the provider establishes the proper milieu — includ-
ing time, noncoercive and open-ended discussion, and mutual respect and participa-
tion— for decision-making. Because of the high disparity in "power" (including edu-
cation, social status, ana income) inherent in the pnysician-patient relationship, ap-
propriate self-eflicacy must frequently begin with elimination of many of the tradi-

tional cues in communication that reinforce this disparity. These would include use
of medical jargon rather than lay terminology; allowing the patient to feel rushed,
inferior or intimidated; disempowering posture or seating arrangements* and con-
descending or sexist language or tone, m this sense, appropriate medical decision-
making must begin with a conscious, noncynical decision to share decision-making
power with patients. Meaningful quality improvement is not likely to occur on a
wide spread basis until these traditional behavioral patterns are modiiied.

In order to understand the anatomy of appropriate decision-making in general
and health care decision-making in particular, it is important to understand how
the various cognitive and behavioral factors involved in decision-making affect pa-
tient satisfaction.

As noted above, outcome expectation is the patient's belief about the likely results
of a proposed procedure (i.e., whether the procedure is likely to meet their expecta-
tion or not). Formulation of appropriate outcome expectations about health care pro-
cedures requires accurate information, including knowledge of the patient's expecta-
tions, risks of the procedure, alternatives to the procedure and expenses involved.
When decision-makers have appropriate outcome expectations, there is a positive
correlation with the eventual satisfaction about their decisions.

Self-efiicacy is patient "empowerment" — that is, the patient's belief that they have
freedom and abUity to choose appropriately between alternatives. High self-efficacy
is positively correlated with satisfaction in decision-making.

Demand effect is the patient's wish to conform to a health care provider's rec-
ommendations. Although providers may experience an initial sense of relief when
they are allowed to control decisions, patients report lower satisfaction with this
kind of decision-m^ing. Furthermore, feelings of coercion are commonly cited as a
basis for malpractice litigation.

In order to improve health care decision-making and optimize satisfaction, the
physician must provide accurate expectations of outcome, take steps to increase pa-
tient's self-efficacy, and decrease inappropriate demand effect. Research in the area
of decision-making in general indicates that steps such as previewing information
during the informed consent process, dividing tne information into categories, re-
peating the information, and encouraging questions, all improve the decision-mak-
ing process. [22,23]

One approach to collaborative medical decision-making and technology assessment
(the PREPARED system) uses a checklist to analyze the appropriateness of a proce-
dure before it is performed. This checklist was the one that has evolved from our
experience of offering alternatives for hysterectomy. The purpose of this pre-proce-
dural analysis is to sequentially review the critical data categories that determine
the appropriateness of the course of action in terms of its risks, costs, and prob-
ability of meeting the patient's expectation. Table 10 lists the PREPARED checklist
or formula for procedural analysis.

The first P stands for the surgical or medical procedure that is being considered
or recommended. A procedure is any course of action — it may be extremely complex,
such as an organ transplant, or extremely simple, such as merely waiting to see if
a symptom wul disappear without treatment. It could be a surreal operation like
hysterectomy, or a blood test, a radiograph, or simply taking medication.

The first R stands for the reason or indication tor the procedure, which should
include both a diagnosis and the harm caused by the condition which create the
need for the procedure or course of action. It is important to document both diag-
nosis and harm, because disease that causes no harm should not be treated. Asymp-
tomatic uterine fibroids are a good example of "disease" which is usually harmless.
The harm caused by disease can usually be described in four categories — loss (or
shortening) of life expectancy, loss of function, suffering, and deformity.

The first E stands for expectation or the clinical outcome or result that the physi-
cian or patient would like to occur as a result of the procedure. For example, the
proper expectation after hysterectomy for symptomatic uterine prolapse which is
interfering with a woman's quality of life would be an improvement in her health-
related quality of life. With the availability of standardized quality-of-life measures,
this should be documented before and again measured after a hysterectomy for this
indication. Expectations generally involve reversal of the four harms described
under reason; that is, prolonging life, restoiing function, relieving suflering, or cor-
recting deformity.

The second P stands for the probability that the desired result will actually occur.
An important task of clinical outcomes research will be to accurately determine
these probabilities for hysterectomy and, in fact, for all health care procedures.

The A stands for alternatives, which should include all other courses of action
that may have the same desired result (expected outcome) as the procedure being
recommended. With respect to hysterectomy, there is almost always at least one.

and sometimes several alternatives. It is important in this category to consider
"watchful waiting" when this is a reasonable alternative.

The second R stands for the risks of the procedure, or the probability that the
procedure will cause harm. The patient should be informed about any deaths that
have occurred from the procedure along with all potentially "life threatening^ com-
plications. All other complications that occur in 1 percent or more of cases should
be explained to the patient at this time. The mortality rate for hysterectomy per-
formed for benign disease is between 1 and 2 per 1,000. This rate is from a popu-
lation-based study and is thought to be more accurate than hospital-based studies.
[24] Overall morbidity ranges from 25 percent to 35 percent, with significant mor-
bidity occurring in about 5 percent of cases.

The second E stands for expense. Expense should include physician and hospital
costs. Patients should also be encouraged to consider indirect or "hidden" costs, in-
cluding lost wages, child care, insurance co-payments, additional medications, and
expenses of potential complications.

The final D stands for the decision at which all interested parties — patient, physi-
cian, a? a family — arrive after careful consideration of all the above information.
Standardrcd pre-procedural analysis utilizing a sequenced checklist such as the
PTIEPAR '"' format should facilitate active patient participation, and result in more
appropriixi decision making.

Figure 3 ({raphicaUy represents a method to separate health care procedures into
those that ar« effective (PREP) and those that are efiicient (ARE). That is, those
that work wiih the least waste in terms of risk and expense. An appropriate choice
should be mf;de from efiicient health care procedures.

TABLE 1

HYSTERECTOMY - HOW ELECTIVE ?

HYSTERECTOMY IS THE HIGH ESTIMATE 17%

ONLY PRACTICAL

(WIDELY AVAILABLE)

ALTERNATIVE LOW ESTIMATE 5%

HYSTERECTOMY IS QUE 83% TO 95%

ALTERNATIVE

BASED UPON ANALYSIS OF 1032 CASES. GAMBONE & REITER

TABLE 2 J

RAND VARIATION STUDIES

123 PROCEDURES - MEDICARE

67 SHOWED AT LEAST A 3 -FOLD VARIATION

SOME HIGHER

• TOTAL KNEE (6 FOLD)

• HIP ARTHROPLASTY (11 -FOLD)

• HEMORRHOIDS (26-FOLD)

TABLE 3

VARIATION IN HYSTERECTOMY RATES
(ESTIMATED 1985)

^ PER 1000 WOMEN AT LEAST
15 YEARS OLD

UNITED STATES 7.0 ♦

ENGLAND AND WALES 3.0

NORTHEAST U.S. 4.8 •

WESTERN U.S. 7.0 ♦

SOUTHERN U.S. 8.3 •

VARIATION WITHIN 2.4 - 8.1

NEW YORK STATE

NATIONAL CENTER FOR HEALTH STATISTICS
TABLE 4 ,

HYSTERECTOMY TRONENESS'

PRIMARY CABE PHYSICIANS

GYNECOLOGISTS 44%

GENERAL PRACTITIONERS 4%

GENERAL SURGEONS 9%

INTERNISTS 3%

PERCENT OF PRACTITIONERS WHOSE PATIENT'S WERE
MORE LIKELY TO UNDERGO HYSTERECTOMY

83
TABLE 6 I

INTERNATIONAL VARIATION

% OF WOMEN WHO HAVE
U.S. AGE (YRS) HAD HYSTERECTOMY

• < 30 2%

40-44 22%

55-59 37%

60 40%

SWEDEN 60 10%

DATA FROM NATIONAL HEALTH SURVEY (SERIES 13, NO. 92 1984)

Tabled Hysterrctomy indication lisi with criteria

Acute cofidiiioii

A-l* PrcfTuncy catistrvphe (e^., trvcrc hemorrhage)

A-2 Severe infection (eg., ruptured luboorarnn itncoi)-

A-S* Opentive coniplicaijon (e.g., uterine pet (oration)
Benign ilisease (pathologic tiaue expected)

B-l LeiomyomaTA ,

a. Symptomatic (eg.. Heeding, prenure)

b. Ajymptomatic (>1S «rk tize, confioa adnexai rraluatitin)

B-t Endometrioaii (diMJna endutmuiiMu, umetpumire to Iwiuwjik (upprcMion or eomervatire nirgery)

B-S Adenomyoab

B-4 Chronic infection (e,g., recurrent pelric inRamraatory diacMc)

B-5 Adnezal maai (e.g.. orarian neoptaim)

B-6 Other (operator-defined, criteria ipecified)
Cancer or lignifiant premalignanl disease

C-\ Invasive dixase of reproductire organi

C-2 Significani preinvasive disease of uterus (high^frade iquamotu intiacpithdial tenon or adenomatous hyperplasia
of endometrium with cellubr atypia)

C-3 Cancer of adjacent or distant organ (gaitniinlestinal, genitourinary, or breast oncer)
Disctmifort (no pailtotogic tastie expected)

D-l* Chronic pelvic pain (negative bparoKopy and nonsurfieal treatment auempted)

D-S* Pelvic relaxation (symptomatic)

D-9* Stress unnary iiKontinencc (puwiive urodrnamic workup)

IM* Recurrent uterine bleeding (unresponsive to liuiinuiie regulation and curettage— normal-«ttd inemi)

D-!* Other (operaior-dehned. criiena specified)
Exieniuting drcuimtances (not specifically indicated but poisibly justified — retjuires preiiperative peer review)

E-l* Sierilitaiion (exientuiing drcuimunces)

E-t* Cancer prophylaiis (e.g., recurrent high-grade squamous iniriKpithclial lesion after eone biopiy or penatent
adenomaioui hyperplasia of etwiomeirium without atypia)

E-S* Other — listing extenuating circumstances

Modified from Cambone JC. Lench JB. SlesinsW MJ, Reiter RC, Moore JC. Otatet Gynecol 1989:73:1045-9. Reprinted with
permission frtxn The American College of Obuetricians and Cynecologisu.

* Denotes indicatiofu where pathologic issmk is mm expeaed to confirm the preoperative diagnoais.

Table 7 Number and Percent of Total Hytttrectomie*
Validated or Verified hv Indiealinn

■ndicition N N rcncal

100

Aone onndibofi

100

A-1 tntrancy uiMiuuflit

(A-3) OfjentiTC conrplKilioo

(B-1) LaomTonm

fist)'

Mkrnnt fof ■cccpablc

171'

Bourn Ditax

291

iltamovc ptiinlatj

B-1 LAomTOfnitt

179

(o-2) fendonnnoi:!

92 '

070)

(B-3) AtfcJiowyoiu

AsymptonttDC

{B-4) ChroRic biftciion

100

h-7 EnXmieinocis

(B-J) Adneul mui (tll<ms( fgr

100

B-4 Chronic mfectioB

niholon)

B-5 Adnexil moi

(B^) Oiha

B-6 Olher

(C-l) Invtaift! taacer

100

(C-2) Pmntliftanl ducuc

100

C-l iiiYVivc ctnccr

(C-3) M)>mi or diittni enerr

C-3 Pmnalirnint discve

(D-I) Chroric pelvK pua

C-3 AdiaocBt or duoni anecr

(D-J) Sympmiunc pehnc

100

D-l Clmxiic pelric pabi

(D-3) Sooi mumij umjiiliiimi:

100

IV7 privic frlamim

(D-5) OOw

ty^ Rtcumnt nicniie bleedinf
D-3 OOie

(E-l) Stcriltzuian

100

(£•}) Cinai pniptiylazii

100

(E-3) mtearc

El Sirrilintion

333

E-3 Ekctin

Loomyomaia ■ione, ie, with ijui^mniu
rcmtioiul nn.
'WHh fltnUiciM idaenl rMholoir

or > 12

Pronie of ttie Single Designated Iixjiation for
Each Hvnirrectomv ii S.n niegn N.vil HcMpial

"jjoikin N PcRoi

2
1
0
50

2
S

II
0

4
0

<
10
7
I
0

0.5
0.1
0

Tool

5S4

100

Table J} Hjntcrvctomy indkation profile and incidence beiore and alter initiation ol the quality
asiurance process

.j^nfrw ptiwd

Study ptried

O'h

t9tl-DK. 1913)

(/•n

l9S4-Dtc.

1917)

ImJitatimm

% '

Hair*

Raw

pVtlmt

Aniir condition

A-l Pregnancy caiaurophe

0.08

OJtl

A-? Se»rre infeoion

0Jt7

0.08

<0.0M

Benign diKue

B-l IjeiommmtfA ■

IBS

1.74

3.10

B-2 tndometrious

0.33

O.IS

B-3 AdetwifnTOtii

0.10

0.45

<0.005

B-4 Chronic inleninn

0.J7

0^6

B-5 Adneaal man

1.17

1.03

B-6 Other

o.ot

Cancer or prenulignant iliiiaii ,

C-l InniiTc oncer

IJ8

1.17

C-? PreinT«ii»e dtxase

0.84

0J8

<0.005

0.01

Di*cotn(on

D-l Chronic pelvic pain

1X5

I.S7

039

<0.000l

D-2 Pel»k reluaiion

0.97

1.04

D-3 Sirrtj unfur)> inconlincTKe

0.93

0.63

D-4 Recurrmi uterine bleeding

1.77

0.95

<0.00l

D-5 Other

Ejilenuaiing circunttunco

E-l Steriliuijon

O.ot

0.04

0.06

0.07

E-S Other

TOTAt

657

100

I3J

748

100

lOJ

<0.00l

*Per 100 gynecologic adminiom.

tx' or lanMailed rnheTi exact icn ai appropriate.

TABLE 9

HEALTH-RELATED QUALITY OF LIFE

GENERAL DOMAINS
LIFE EXPECTANCY

FUNCTIONAL CAPABILITY

PHYSICAL STATUS

SYMPTOM SEVERITY

PSYCHOLOGICAL WELL-BEING

INTERPERSONAL FUNCTION

WORK STATUS

EXAMPLES
5YEAR SURVIVAL

SELF CARE, MOBILITY

NUTRITION

PAIN

MOOD, DISTRESS

FAMILIAL, SOCIAL, SEXUAL

EMPLOYMENT

imit 1^

QUALITY OF CARE: APPROPRIATENESS OF
HEALTH CARE PROCEDURES

THE "PREPARED' FORMULA

P rocedure: The course of action being considered

R eason: Indication for procedure

E xpectation: Beneficial outcome of procedure

P robability: Likelihood of meeting the expectation

A Iternatives: Other procedures and options

R isks: Potential harmful outcomes of procedure

E xpense: All direct and Indirect costs

D ecision: Fully informed patient choice

2 20

in
ui in

K O
>- <

0 2
^ °i
" 7i

teJ O

'i!5

1 o
9

111

r - 0.04*
m»«in •• 13.5

soi-ar

I I 1 1 1 1 H 1-

3Ro«mm aesn 4mtsrai>xB«m
BEFORE OA PROCESS

• •

r-0.15
maen •■ 10J
SOI-OJ

-t — I I I I I I I I — I I I — I I I — • — I

tST

IMS IWf

AFTER QA PROCESS

Fig. I Time tetia analrib of quanerlr hTHerwtotnr m«a befon f«^ tinirt) and after fciawtf
cirrbi) the qualiiy aauranrc procas. The tigniBcanl decreax in man cumutaiive incidence <ISJ
w lO.S, p < 0.001) b IKN a gradual decline orer lime boi raiher a dixrete change that occurs after
institution of the qualiljr assurance process in January I9M.

PATIENT
CONTROL

COLLABORATION

PHYSICIAN
CONTROL

PATIENT
AUTONOMY

PATIENT
ABDICATION

FIGURE 2. The health care decision-making continuum.
U.S. practice is weighted toward physician control.
(Modified from Baliard-Reisch)

fl(i»4l^3

ALL HEALTH CARE PROCEDURES

1. National Center for Health Statistics. Graves, EJ, National Hospital Discharge
Survey: Annual Summary, 1990. yitwl nnd Health Statistics. Series 13 No. 112,
Washington, D.C.: Government Printing Office. 1992 (DHHS publication no. (PHS)
92-1773.)

2. National Center for Health Statistics. Pokras R, Hufnagel VG. Hysterectomies In
the United States, 1964-84. Vital and Hep|th Statistics Series 13 No. 92 Washington
DC: Government Printing Office, 1987 (DHHS publication no. (PHS) 88-1753.

3. KIrschner M., "Where Do Your Fees Fit in?" Mftrilcat Economics Oct 1990 Ed pp
76-106, Medical Economic Co., Inc. Orydell NJ.

4. Gambone JC. Lench JB. SleslnskI MJ, et al: Validation of Hysterectomy
Indications and the Quality Assurance Process. Qhstgtrlcs and GynecotOBY 1989; 73:
1045-1049.

5. Gambone JC. Reiter RC, Lench JB: Quality Assurance Indicators and the Short-
Term Outcome of Hysterectomy. Ohstetrlcs ft Gvnecoloov 1990; 76-841-845

6. Carlson KJ. Nichols DH. Schlff I: Indications for Hysterectomy. The N9W England
Jq^^^PPI nf Medicine. March 25. 1993; 856-860.

7. Coulter A, McPherson K, Vessey M; Do British Women Undergo Too Many Or Too
Few Hysterectomies? Social SclericB Medicine 1988 27:987-94

8. DomenlghettI G, LuraschI P, Marazzi A; Hysterectomy And Sex of the
Gynarologlst. New England Jounat of Medicine 1985; 313:1482.

9. Dicker RC, Scally MJ, Greenspan JR, et^al. Hysterectomy Among Women of
Reproductive Age. JAMA 1982: 248:323-7.

10. Gambone JC, Relter RC; Quality Improvement In Health Care. Current Problems
In Obstetrics. GvnecoloQV and Fertllltv. September/October 1991: 169-175.

11. Roos NP: Hysterectomy: Variations in Rates Across Small Areas and Across
Physicians' Practices. AJPH April 1984, Vol. 74, No. 4.

12. Relter RC, Gambone JC, Lench JB: Appropriateness of Hysterectomies
Performed for Multiple Preoperative Indications. Obstetrics and Gvnecoloov.
December 1992 Vol. 80, No. 6 pp 902-905.

13. Gambone JC, Relter RC. Non-surgical Management of Chronic Pelvic Pain: A
Multidiscipllnary Approach. Clinical Obstetrics and Gynecology. March 1990. Vol.
33, No. 1 pp 205-212.

14. Dyck FJ, Murphy FA, Murphy JK, et al. Effect of Surveillance on the Number of
Hysterectomies In the Province of Saskatchewan. New England Journal of Madtelna
1977; 296: 1326-8.

15. Relter RC, Gambone JC. Demographic and Historic Variables In Women With
Idiopathic Chronic Pelvic Pain. Obstetrics and Gynecology 1990, 75: 428-32.

16. Gambone JC, Relter, RC, Lench JB, et al: The Impact of a Quality Assurance
Process on the Frequency and Confirmation Rate of Hysterectomy. American Journal
of Obstetrics and Gvnecoioov August 1990, Vol. 163 No. 2 pp 545-550.

17. Kaplan RC, Health Outcomes Models for Policy Analysis. Health Psychology
1989:8:723.

18. Kaplan RM. Behavior as the Central Outcome In Health Care. American
Psychology 1990:45:1211.

19. Fisher S, Doctor Talk/Patient Talk: How Treatment Decisions are Negotiated in
Doctor/Patient Communication. The Social Organization of Doctor-Patient
Communication. Center of Applied Linguistics. Washington DC 1983, p 137.

20. Capian AL, Informed Consent and Provider-Patient Relationships In Rehabilitation
Medicine. Arch Phvs Med Rehab. 1988: 69: 312.

21. Greenberg LW, Jewett JS, Celick RS et al. Giving Information for a Life
Threatening Diagnosis. American Journal of Diseases In Children 1984:138:649.

22. Ley P, The Psychology of Compliance. In Oborne P, Gruneberg M, Eisen R (eds):
Research In Psvchoiogy and Medicine. Academic Press, London 1979: Vol. 2 p 221.

23. Ballard-Relsch. Health Care Providers and Consumers: Making Decisions
Together. In Krebs GL, Thornton BC (edo): Health Communication 2nd ed. Waveiand
Publishing Co., New York. 1992

24. Loft A, Anderson T, Bronnum-Hasen H, et al: A Danish Population Based Study,
1977-1981. British Journal of Obstetrir^ ft Gvngecolooy 1992; 98:147-154.

Senator MncuLSKi. Dr. Bachmann, I know you are going to talk
to me about clinical trials.

Dr. Bachmann. Yes. I think that's a nice ending for this session,
because from all the questions that have been raised and all the
problems, I think that is probably the best way to answer the ques-
tions that we have raised today.

What I'll do is basically summarize the pros and cons of what I
see as why we should have a clinical trial for this question.

I first became interested in this question in 1987, when it was
the issue of the year for the American College of Obstetricians and
Gynecologists, and I was the one who researched it after receiving
the grant. And I have four reasons why we should do a clinical
trial.

No. 1 is the magnitude of the problem, which I don't have to reit-
erate here, with tne $3 billion annual cost, etc., etc.; one in three
women has a hysterectomy before she reaches age 60. But also, the
methodology exists. We have done it for hypertension, we have
done it for myocardial infarction, where we have looked at surgical
versus medical management, and we have come up with real guide-
lines; the same with hypercholesterolemia. So we have the meth-
odology. We also have the end-points. We can study mortality. We
can study serious morbidity. And we can also adapt what is avail-
able now for quality of life and the financial aspects.

It is ethically supportable, since only 10 percent of
hysterectomies are done for cancer, and 90 percent are done for
nonlife-threatening conditions.

And the fourth reason to do a clinical trial would be because of
human suffering, which is obvious. We saw three patients today,
and this can be multiplied many, many times.

What are the cons? Well, the first is obviously the expense, but
I think that depends on the number and types of outcomes studied
and the methodology of ascertaining them — and again, I have
many references of studies that have been done where costs have
been controlled.

The other is generalizability of results. Again, this depends on
the appropriate inclusion and exclusion criteria. And I would also
propose that we organize a hysterectomy registry which would run
parallel with the clinical trial.

What would be the first step? I think a pilot study would be the
best way to approach a large-term clinical trial where we would
find out the feasibilitv of a Targe-scale clinical trial, would outline
a scientifically souna protocol, we could estimate costs, and we
could develop the protocol for a multicenter, prospective, random-
ized study. And obviously, the proposed clinical trial is a population
of women who would be candidates for hysterectomy for nonlife-
threatening conditions; and the design would be obviously a ran-
domized, clinical, multicenter trial where we would look at medical
versus surgical management. Surgical management, again, \yould
go for abdominal/vaginal hysterectomy, laparoscopically assisted,
endometrial ablation, myomectomy, laser laparoscopy, but we
would also look at medical management — and I find that medical
management can also be expectant, where we don't have to do any
tvpe of intervention — plus hormone therapy, nonhormonal
therapy

Senator MncuLSKl. Dr. Bachmann, our very able stenographer is
going to graduate from medical school in about an hour and a half.
Could you just go more slowly with the procedures so that she can
follow you?

Dr. Bachmann. OK. I was just thinking about the time con-
straint.

Senator MncULSKl. Well, I don't think you need to enumerate
them. We are going to take your personal opinion, and put it in the
record.

[The prepared statement of Dr. Bachmann follows:]

Prepared Statement of Gloria A. Bachmann

HYSTERECTOMY: NEED FOR A CLINICAL TRL\L

The topic of Hysterectomy was the American College of Obstetricians and Gyne-
cologists Issue of the Year in 1988. As the recipient of this grant I did extensive
research into the medical, psychologic and socio-cultural issues associated with hys-
terectomy and wrote a paper discribing my findings (Ref.l). Since then I have in
continued to do research in the area oi hysterectomy and through this study, as I
have previously reported, I have come to the conclusion that in spite of the vast
body of literature on hysterectomy and the major developments that have occurred
in the operative, clinical, epidemiologic, pathophysiologic and psychosexual aspects
of hysterectomj[, the indications for hysterectomy to alleviate patient suffering re-
main to be clarified (Ref. 2 and 3). Since most hysterectomies are performed to im-
prove quality of life, the prevalence, natural history and personal and existential im-
portance of the sjncnptoms associated with benign disorders that lead to a large pro-
portion of hysterectomies must be studied. Further, the effect of hysterectomy on
the alleviation of the symptoms prompting the surgery has not been adequately re-
searched in a formal way. Appropriate methodologies must be applied for
ascertaining the short and long-term beneficial and adverse affects of hysterectomy
on pain, physical, hormonal and psychosexual State and overall quality of life. Like-
wise, alternatives to hysterectomy should be carefully examined to determine their
effectiveness in comparison to hysterectomy, to evaluate their short- and long-term
adverse effects in comparison to those of hysterectomy and to study their direct and
indirect expenditures CRef.3).

An outline of the pros for a clinical trial are several and include:

1. The magnitude of the problem. In the United States one in three American
women has a hysterectomy before she reaches age 60 at a cost of 3 billion dol-
lars annually. From this procedure an estimatea 250 to 5,500 deaths occur an-
nually.

2. The methodology exists. To determine whether hysterectomy is necessary
at the current rate of medical management is as effective can be drawn from
the methodologies used in other clinical trials that have looked at surgical ver-
sus medical management such as the trials examining coronary artery disease.
There are several studies that have looked at coronary artery bypass grafting
versus medical management of the patient with coronary artery disease. These
trials, such as the CASS, European, and VA studies have changed medical prac-
tice. As well, the methodology of study end points is also available, (e.g. mortal-
ity and serious morbidity) or can be adapted from currently available protocols,
(e.g. quality of life, financial, etc.).

3. A clinical trial is ethically supportable. Since 10 percent of hysterectomies
are not done for life threatening conditions, randomization to medical or sur-
gical intervention is possible.

4. Human suffering. Many women report adverse medical, psychological and
emotional changes after hysterectomy that effect not only themselves, but their
families.

An outline of the cons of a clinical trial include:

1. The expense of the study. However, the expense of the study depends on
the number and types of outcomes studied and the methodology of ascertaining
them. Therefore, the cost of the study can be adjusted.

2. GeneralizabUity of results. Again, this important issue depends on the use
of appropriate inclusion and exclusion criteria. The organization of a hyster-
ectomy registry parallel with the cUnical trial would also insure generahzability
of results.

A first step before a clinical trial would be a pilot trial which could determine the
feasibility of a large scale clinical trial, outline a scientifically sound protocol, esti-
mate costs and develop the protocol for a multicenter perspective randomized study.
Below is an outline for a proposed clinical trial:

1. Population. Women candidates for hysterectomy for nonlife threatening
conditions.

2. Design. Randomized clinical trial of medical versus surgical management.

3. Surreal management. Use of either abdominal hysterectomy, vaginal hys-
terectomy, laparoscopic hysterectomy, endometrial ablation, myomectomy or
laser laparoscopy.

4. Medical management. Use of either expectant management, hormonal ther-
apy, nonhormonal uierapy or lifestyle modification.

5. Outcomes: mortality, morbidity, quality of life and resource utilization.

6. Duration: depends on endpoints.

7. Power: depends on endpoints.

As I have previously reported, clinical trial methodology has been developed in
other disciplines where world wide clinical practice has changed as a result of these
trials, e.g. treatment of hypertension, myocardial infarction and
hypercholesterolemia. It can be ai^gued that hysterectomy should also be studied in
the same way. While the FDA requires extensive safety and efficacy studies before
approving new drugs, surgical procedures in general are not subject to this same
scrutiny. Outcomes from large clinical trials have been criticized mainly because of
the expense incurred and concerns regarding the general applicability of the find-
ings. However, they still remain the major tool in deciding the appropriate course
of action in common clinical problems. In addition, newer techniques utilizing very
well defined protocols with limited sharply outlined dependent variables and a large
number of investigators have allowed the conduct of veiy large (e.g. 20,0000 pa-
tients) clinical trials with moderate expenditures and generaUy accepted results
with wide clinical applicability. Knowledge regarding hysterectomy versus
nonsurgical alternatives or surgery with preservation of the uterus obtained from
a large scale clinical trial would allow more informed choices to be made by both
the physician and patient regarding the circumstances where hysterectomy is a
treatment of choice (Ref. 3).

In summary, the current criteria used to decide whether hysterectomy is appro-
priate for a given patient must be more objectably scrutinized. The data necessary
to refine the indications and evaluate the various medical, psychological and fiscal
outcomes can be obtained by a well designed clinical trial. The ^at epidemiologic
importance of hysterectomy, the second most common major surgical procedure, jus-
tifies this approach (Ref. 3).

RciGrGIlCGS'

1. Bachmann, GA, Hysterectomy, A Critial Review. The Journal of Reproductive
Medicine, Vol. 35, No. 9, September 1990.

2. Bachmann, GA, Psychosexual Aspects of Hysterectomy, WHI Vol. 1, No, 1, Fall
1990

3. Bachmann, GA, Hysterectomy: Is there a need for a clinical trial? Maturitas

15 (1:3-6, 1992.)

Personal Opinion

Hysterectomy: Is there a need for a clinical trial?

Gloria A. Bachinann

DIvUhn of Obstetrics and Gynecohffy, Unhentiy of Medicine and Dentistry of New Jersey-Robert Wood
Johnson Medical School. New Brunswick. New Jersey (USA)

Hysterectomy, the second most common operation today, with the majority of cases done in
perlmenppausal women usuaify performed For symptomatic relief. Consequently controversy exists on the
appropriateness of indications. A clinical trial Is proposed to study this question.

Key words; hysterectomy; perimenopausal; clinical trial

Introduction

Since the first hysterectomy, described In the third century A.D. writings of
Soranus, this operation has become widely accepted as a curative and pallalive
procedure and is the second most frequent major surgical procedure in the United
Slates today |l|. After peaking at an annual level of over 725 000 operations in 1975,
procedures are performed annually at a hospital cost of approximately three billion
dollars |2). Hysterectomy is most frequently done during the perimenopausal years
and the majority of hysterectomies are performed to relieve symptoms rather than
for life threatening pathology. There exists a marked variation of hysterectomy rates
among geographic regions and socioeconomic strata (2]. In addition, unlike most
other surgery, hysterectomy has been associated with various psychosexual distur-
bances and is viewed by some women as a threat to their perception of femininity |3I.

Prior to this century, hysterectomy carried a very high mortality rate approachitig
90% such that the operation was performed only when the woman's life was at grave
risk. Although technological developments in medical procedures and equipment,
blood banking, anesthesia, antisepsis and antibiotics have lowered the mortality rate
to approximately 12/10 000 procedures and in so doing have liberalized indications
for this operation, the financial models of health care delivery are moving in the
direction of reduction in health care expenditures and in so doing are placing more
restrictions on the indications for the performance of hysterectomy I4j.

Correspondence to: O.A. Bachmann. Division of Obstetrics and Gynecology, University of Medicine and
Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.

Controversy exists today on the appropriate indications for hysterectomy,
especially when done in asymptomatic or minimally symptomatic women without
life threatening disorders or in cases where no uterine pathology is identified. The
medical professions' reexamination of the clinical necessity to perform hysterectomy
for symptomatic relief is in part due to the imperative to contain health care costs
as well as such factors as the rapid rise of surgeries performed in this country, the
recent advances in surgical technology (e.g. lasers), which often allow uterine reten-
tion, the increasingly vocal patient advocate groups who often claim that many
hysterectomies are not surgically warranted and the belief of some professionals and
consumers that the effectiveness of many medical practices, such as hysterectomy,
is questionable or, in certain instances, entirely lacking (5J.

Indications to perform a surgical procedure fall into three broad categories: to
prevent mortality, to restore function and alleviate symptoms. Uterine removal as
part of the treatment regimen often is a necessary and potentially lifesaving pro-
cedure in patients with pelvic cancer. Hysterectomy is often indicated when uterine
pathology interferes with urogenital function or is impairing on other organs (e.g.
large leiomyomala, uterine prolapse). The justification of hysterectomy to relieve
suffering is the area of medicine on which the current debate centers; no set objective
criteria defining these indications for hysterectomy are universally agreed upon.
Therefore, the appropriateness of the surgery for each case involving benign disease
must be individualized and disagreement among professionals is expected. At a re-
cent American College of Surgeons meeting, it was reported that in a California
study, 2/3 of 650 consecutive proposed hysterectomies were deemed inappropriate
by a quantitative screening method used in precertification. After additional physi-
cian scrutiny, more than 1/3 of the operations were still vetoed (6]. However, the
effect of screening programs such as this one on the patient's health has not been
adequately studied. It is possible that by avoiding or postponing hysterectomy,
women may derive either untoward or beneficial health effects.

Today, the decision to perform an operation such as a hysterectomy does not rest
solely with the physician or the physician with patient input as in the past but the
decision is infiuenced by factors outside of the doctor's office. That is, the decision
is often made after consideration of the interests of third party payers, usually
wishing to minimize the number of 'unnecessary' procedures; hospital ad-
ministrators who may wish to maximize fiscally favorable hospital admissions and
welcome the performance of elective, low risk operations on otherwise healthy pa-
tients; quality assurance programs interested in adequate documentation and
adherence to preset, rigid criteria; often mandatory second opinions seeking to in-
sure valid indications for the proposed surgery; the standard of practice in the
geographic region; the patient in consultation with her family and friends; and final-
ly the medical judgment of the physician. Therefore, uniformity in selecting ap-
propriate patients for hysterectomy is not often feasible because absolute indications
for hysterectomy are difficult to define and professionals, viewing hysterectomy
from different perspectives, will often disagree on the appropriate weights to be
assigned to the different factors (mortality, suffering, emotional factors, finances,
etc.) that come into consideration when the decision for hysterectomy is made. Un-
fortunately, large scale, double blind studies evaluating pre- and postoperative quali-

68-667 - 93 - 4

ty of life Issues are nol available Ihat document patient outcome either with or
without uterine extirpation and therefore objective criteria often cannot be applied
in the decision making process.

Need for i clinical trial

Since indications for hysterectomy have not been universally agreed upon, a major
question that has not been satisfactorily answered Is whether the current rate of
hysterectomy, where the majority of cases are performed for benign conditions, Is
appropriate. While attempts have been made to answer this question using historical
data, small prospective studies and metaanalytical techniques, it appears that this
question also can only be definitely answered wfth a randomized clinical trial with
short and long term mortality and morbidity as well as quality of life outcomes and
symptom relief as endpoints.

In spite of the vast body of literature on hysterectomy and the major developments
that have occurred in the operative, clinical, epidemiologic, pathophysiologic and
psychosexual aspects of hysterectomy, the indications for hysterectomy to alleviate
patient suffering remain to be clarified. Since most hysterectomies are performed to
improve quality of life, the prevalence, natural history and personal and existential
importance of the symptoms associated with benign disorders that lead to a large
proportion of hysterectomies must be studied. Further, the effect of hysterectomy
on the alleviation of the symptoms prompting the surgery has not been adequately
researched in a formal way. Appropriate methodologies must be applied for ascer-
taining the short and long term beneficial and adverse affects of hysterectomy on
pain, physical, hormonal and psychosexual state and overall quality of life. Likewise,
alternatives to hysterectomy should be carefully examined to determine their effec-
tiveness In comparison to hysterectomy, to evaluate their short and long term
adverse effects In comparison to those of hysterectomy and to study their direct and
Indirect expenditures.

Clinical trial methodology has been developed In other disciplines where
worldwide clinical practice has changed as a result of these trials (e.g. treatment of
hypertension, myocardial infarction and hypercholesterolemia). It can be argued
that hysterectomy should also be studied In the same way. While the FDA requires
extensive safety and efficacy studies before approving new drugs, surgical procedures
in general are not subject to this same scrutiny. Outcomes from large clinical trials
have been criticized mainly because of the expense incurred and concerns regarding
the general applicability of the findings. However, they still remain the major tool
In deciding the appropriate course of action in common clinical problems. In addi-
tion, newer techniques utilizing very well defined protocols with limited sharply
outlined dependent variables and a large number of Investigators have allowed the
conduct of very large (e.g. 20 000 patients) clinical trials with modest expenditures
and generally accepted results with wide clinical applicability (7). Knowledge regar-
ding hysterectomy versus non-surgical alternatives or surgery with preservation of
the uterus obtained from a large scale clinical trial would allow more Informed
choices to be made by both the physician and patient regarding the circumstances
where hysterectomy is the treatment of choice. Studies comparing aorto-coronary

bypass surgery to medical therapy or to percutaneous transluminal coronary
angioplasty conducted by NIH as well as abroad may serve as a model (8).

Summary

In summary, the current criteria used to decide whether hysterectomy is ap-
propriate for a given patient must be mor* objectively scrutinized. The data
necessary to refine the indications and evaluate the varied medical, psychological
and fiscal outcomes can be obtained by well designed clinical trials. The great
epidemiologic importance of hysterectomy, the second most common major surgical
procedure, justifies this approach^

References

1 Benrubl OA. History of hysterectomy. J Pit Med Assoc 1988; 75: 533-53S.

2 Hysterectomy \n the United Slates. 1965-84, Vital Health Stal 1988; 13.

3 Bnchmann GA. Psychosexual aspects of hysterectomy. Women's Health Issues 1990; I: 41-48.

4 WIngo PA. Huezo CM, Rubin GL et al. The mortality risk associated with hysterectomir. Am J
Ohstet Gynecol 1985; 152: 803-808.

5 Bachmann OA. Hysterectomy: a critical review. ) Reprod Med 1990; 35: §39-862.

6 Avoiding unnecessary hysterectomies. Ob Oyn News 1990; 23: 2.

7 In-hospital mortality and clinical course of 20,891 patients with suspected acute myocardial infarc-
tion randomized between alteplase and stretokinase with or without heparin. The International
Study Group Lancet 1990; 336: 71-75.

8 Bari. Cabri, East, Gab! and KJta; coronary angioplasly on trill (cdilorlal). Lancet 1990; 335:
I3I5-I3I6.

Dr. Bachmann. OK. They are all here. We could do surgical
management, the medical management, we would look at the out-
comes, and again, it would be mortality, morbidity, quality of life,
and resource utilization, which I think is really more important
than actual billing, since we know billings really vary from hospital
and hospital and geographic area to geographic area.

The duration of the study would depend on the end-points that
we would choose, and the power would also depend on end-points.
So my proposal would be a pilot trial that would lead to a
multicenter clinical trial to study this problem, rather than piece-
meal it with looking at fibroids, or ovarian conservation versus re-
moval, etc. J

Senator Mikulski. Well, thank you very much, and I didn t mean
to rush you; I was just helping her out, and I know that for a few
minutes afterward, she might need to ask you a question or two
about that. But thank you very much.

What is so interesting here are the three studies — the famous
Maine study that has caught the attention of so many people,
which is provider-based; an alternative that was really consumer-
driven; and then. Dr. Bachmann, your call for a clinical trial.

I am going to go right to you for a question that I find shocking.
Do you mean to tell me that there has never been a clinical trial
on hysterectomies?

Dr. Bachmann. Never.

Senator Mikulski. Never. I mean, we've got clinical trials on any
number of procedures — none of which I want to minimize, and I
could rattle off some, but it's your life— but there has never been
a clinical trial done? Why not, when the two most significant proce-
dures that occur in the United States of America are Caesarean
and hysterectomies, and we've got guidelines and a whole specialty
devoted to it. So it is not like it is an obscure new procedure that
might be unique to the Northeast corridor of the United States.

Could you tell me why, in your estimate, a clinical trial was
never done? Is it apprehension of methodology, or what?

Dr. Bachmann. I think we touched on it beforo when we men-
tioned the FDA and the clinical and efficacy studies that are re-
quired for new drugs; but there really is no such monitoring of sur-
gical procedures, and I feel that that is probably a great negative
in this whole area of women's health care, that we really don't have
any type of an FDA that looks at surgical procedures as they

Senator Mikulski. Which went to my question — do you remem-
ber when I asked where do we go for the safety — 1 mean, the FDA
is so clear in its approach to safety and efficacy

Dr. Bachmann. Exactly, and I tnink

Senator Mikulski. Well, where would you recommend, number
one, that that occur, and number two, where would you recommend
that we could promote a clinical trial on hysterectomy, because I
think it would provide very important scientific knowledge?

Dr. Bachmann. Well, the Women's Health Initiative has just
been kicked off with the 16 vanguard studies, and it could either
be an ancillary part of that study, because it is such an issue that
involves the 40-year-old and up, but again, as Dr. Widen said, 30
percent of hysterectomies were women Below 40, so we may not hit

that group. That's why I reallv think it deserves its own clinical
trial. Most of the large clinical trials have been NIH-funded, and
in Europe, I think there are a conglomerate of European
countries

Senator MncuLSKi. One of the places to look would be NIH, and
to consult with Dr. Pinn and others; is that correct?

Dr. Bachmann. Correct.

Senator Mikulski. And of course, we would look forward to the
estimate of what such an undertaking would be. But actually, I
think what you are talking about here would be a plurality of re-
search modalities — one, a clinical trial on the efficacy of hyster-
ectomy; then, further research on the alternative modalities that
have been discussed; and last, but not at all least, additional re-
search on patients that are more consumer-driven, along with the
Gambone-Reiter-Lench studies — is that right, that essentially what
you have done here is show the different techniques for the re-
search that need to be done, so there is not going to be a single
approach.

Dr. Bachmann. That's right. And I think we really could start
with a pilot study where we can start developing really sound sci-
entific protocols, because a lot of the studies now really self-select
women who are already having hysterectomies, so how can you
really get a lot of information if you aren't randomizing them?

Senator MiKULSKl. Well, I think we are all familiar with the
methodology of clinical trials, and of course, the Congresswomen
and myseliT with the support of many of my colleagues in the Sen-
ate, pushed for the establishment of the Office of Women's Health
because women were being excluded from clinical trials. Now, I
think we are ready for some additional steps to be taken. So I
think that's an excellent, excellent set of recommendations.

I'd like to go to you. Dr. Widen. You pay the bills at the Blues,
and you raised a very important issue around cost containment,
and that there are a couple of tools for reducing cost, one of which,
of course, is to reduce the paper work involved with the insurance
that Dr. Morley spoke of, but then you also raised the issue of un-
necessary procedures and treatments. That gets tricky, because we
are in the United States of America. We don't ration health care;
nobody in America wants to ration health care; we aren't going to
get into that; we don't pick and choose so that an 18-year-old man
whose family might have a trust fund could get a bypass, as did
my 68-year-old mother on Medicare. That's America, and I would
say that all of us have benefited from that.

How would you recommend that, without centralized bureauc-
racy, big government — ^you know, we don't want to bring "comrade
care" to tne United States of America — ^how, then, could we dimin-
ish unnecessary hysterectomies so that we could safeguard the
availability of the necessary? Could you share that with us?

Dr. Widen. I think that is a very important question. I just want
to remind us all that when Medicare came along, health care costs
increased enormously in the United States, and it was in part be-
cause Medicare covered everything, and there were really no guide-
lines as to what was efficacious and what was appropriate.

I think the eventual answer is for the medical profession, expert
panels of the medical profession, to really move ahead full force,

perhaps working with the NIH and academic centers, in developing
practice protocols. It is interesting that the American College of
Physicians actually came out for a position in which new health
care legislation would include the mandate that physicians' per-
formance could be measured against these practice protocols. And
believe it or not, we have the computer capability of doing that
right now. Just on the basis of claims and so forth, we can compare
what physicians are doing against these practice protocols. And we
think that if physicians are deviating from these practice protocols,
if they are doing too much, they have to be informed about this;
they have to be educated.

I know there is evidence that when physicians are presented
with evidence that shows that they are deviating from the gen-
erally-accepted practice patterns of tneir fellows — and I use that for
both sexes — ^they will generally course-correct.

Senator Mikulski. So you think, then, Dr. Widen, that it really
should lie with utilization review groups that are peer-based, that
are physician-based?

Dr. Widen. That are physician-based. I would emphasize that —
not insurEince industry-based, but are physician-based.

Senator Mikulski. That's what I mean.

Dr. Widen. I do feel that has got to be incorporated into the law,
because if we don't do that, if we don't address the issue of utiliza-
tion control in the United States where, frankly, there is so much
evidence of excess utilization as compared to other developed indus-
trial coimtries, then we are just going to spend more money for the
providers.

Senator Mikulski. Is it your sense that the physician community
would then feel — right now, I know that one of the concerns about
health insurance reform is that there is going to be some
nonphysician at the end of an 800 number, telling a doctor what
the heck to do or what the heck not to do, and I share that concern.
They are dedicated, have worked hard, and make many sacrifices
to be a physician. And that is why I don't want big bureaucracies
saying to doctors what you can do or not do, or 800 numbers.

Dr. Widen. I agree with you, and that's why I mentioned that
I still practice, because I hear this from my colleagues all the time.
But if we don't introduce some protocols, some guidelines

Senator Mikulski. So practice protocols. But then you are saying
physicians would feel comfortable, or at least more comfortable, if
in fact they were being judged by their peers, who themselves have
faced similar or parallel clinical situations; and some physicians
might have higher utilizations, but they might be dealing with a
greater at-risk population; am I correct?

Dr. Widen. Senator Mikulski, you hit it right on the head. I
agree with everything you have said. Some physicians would feel
more comfortable. I have to tell you that I think that some physi-
cians— a minority — would feel uncomfortable with any kind of re-
view that they were subjected to, and I think that that's unfortu-
nate. I think more physicians nowadays are very accepting of the
concept that our work as physicians has to be subjected to review.
And I think that physician-developed guidelines would be accept-
able to the overwhelming majority of physicians and would help us
not only in utilization management, but in quality management.

and indeed would probably help a great number of physicians in
terms of dealing with the malpractice threat.

Senator Mikulski. But that then goes to the fact that we do need
a place that is both developing practice protocols, in consultation
with the academies and the professional associations, and then de-
termining the efficacy of these. It seems, though, that as Dr.
Bachmann has said and others have said, this is kind of scattered.
When one of your colleagues, any of the colleagues, prescribe a
pharmaceutical, they know where it is, they know what has hap-
pened at FDA, and they can call up, get the original^ studies, do a
review of the literature, and so on— tut that doesn't seem to be
true of both surgical procedures and medical treatments.

I wonder if anyone on the panel — and I'm not here to reorganize
HHS, but this is one of the issues, and I want you to have a one-
stop shop, or at least be able to call, for us to be able to do that
as we look at the funding of efficacy. You know, I believe it was
Dr. Morley who said the term "outcome research" sounds so cold.
I mean, what is the outcome? There is more to an outcome than
an outcome, sometimes, because of the impact on a family; it is not
only the success of the procedure.

Where do you think that ought to go? Do you want to comment,
Dr. Carlson, Dr. Gambone?

Dr. Carlson. I would like to venture that there should be a col-
laboration between those interested parties that are now barriers
to this kind of research getting done — the insurers and the govern-
ment both, working together to fund these projects.

Also, we have left the patients out here. The patients have to be
willing to participate in studies in order to advance medical knowl-
edge. And often, through lack of information about how research is
done, patients are unwilling. We need to focus on them, too. And
patients are also a very important focus for cost containment ef-
forts to complement the kind of policing of physicians that Dr.
Widen has advocated. Patients who are educated about their op-
tions will make better choices, and oft«n choices that don't involve
expensive procedures.

Senator Mikulski. Dr. Carlson, I agree with everything you said,
but I think the word "policing" is not one I would want to introduce
into the debate, because I think what we are talking about is how
we contain costs, ensure clinical practice, where physicians might
be overutilizing the system, for it to be brought to their attention —
but again, I think if people feel "big brother" is going to be telling
them what to do, then there is less likelihood for there to be com-
pliance, and a resistance to the reform movement. And I know
what you intended, but I am associated with the liberal side. I talk
to Mrs. Clinton a lot — and Mrs. Clinton, by the way, is talking to
the Senate Republicans and Democrats a lot — and this is what we
are trying to get across, that we are for the reform, but hassle-free
medicine has to occur; cost containment has to be done in a way
that for physicians to then subject themselves to this type of scru-
tiny, that they get "good guy/good gal" bonuses in other areas — pa-
perwork reduction, a more contemporary look at malpractice, and
so on — so that the physicians don't feel that they are being viewed
as part of the problem rather than part of the solution.

100

But let's go on to the patients. You talked about using them not
only in clinical trials, but Dr. Gambone and Dr. Carlson, your work
showed that consumer-oriented research has really led to some
startling results. Could you share with us how you think we could
promote that? And you talked about the attitudes toward utiliza-
tion.

Dr. Gambone. Yes, I sure can. I think it is very important that
we include the patient in the quality loop, so to speak. I think we'll
all be very surprised at how intelligent informed consumers can be
about these choices. You made a very important observation earlier
and documented that unlike drugs, which are tested for safety and
efficacy in the United States, surgical procedures are not. Surgical
instruments are tested by the FDA, but the procedure per se is not.
And I think there is a lot of conftision even among the public in
that very slight nuance.

Senator MncuLSKl. They know more about the laser beam than
laser surgery.

Dr. Gambone. Exactly. We know that the laser beam works, it
will get from point A to point B, but the actual procedure that uti-
lizes the laser beam is not tested by any agency, and that's wrong.
And it should include information from the patient consumer, be-
cause I think well all be surprised at how very good they are at
this kind of activity.

Senator Mikulski. Dr. Gambone, did you find in your study that
patients are afraid — that they are afraid to come to talk to you in
the first place; that when you do talk to them, they don't always
hear what you've got to say — that just the fear of comine, the fear
of finding out in some ways affects what they undertake: I wonder
if you could elaborate on that, because it goes to the time that it
takes. One of the other physicians talked aJbout just the time that
it takes. Could you share that with us, because I also think that
it has ramifications for that. Dr. Ravnikar talked about her pre-op
interviews, for example.

Dr. Gambone. Yes, she mentioned that she does take the time,
and I think that is important. It is very time-consuming, but it is
one of the more important aspects of a pre-procedural agreement,
so to speak, between the surgeon and the patient.

We have to focus more on patient activity in this decisionmaking
process; otherwise we'll end up with a sort of top-down reform of
health care which everyone is going to react negatively to, and
what we really need is we need to get to the patient consumer and
have them participate in this decisionmaking process. And it can
be done. They are fearful. Research shows that over 50 percent of
patients leave the doctor's office really not knowing what to do or
what was said pretty much for the entire time. They are very con-
fused, and they are frightened. They need some kind of tool or
method that can help them to approach this session, particularly
a preoperative session, where a very high-consequence procedure is
being discussed.

So that we think more research is needed in the decisionmaking
process that occurs in health care, and I think at least $100 billion
could be saved or is recoverable in this area alone.

Senator MiKULSKl. Dr. Widen, would you pay for that type of
consultation, like the pre-op interview — when I say "you," I'm talk-

101

ing about the insurance companies — this type of consultation, and
also for the reimbursement, for example, for a team approach in,
say, the ob-gyn's office? One of the earlier witnesses talked about
the empowerment and the positive role that nurses and nurse prac-
titioners play. That deals with overhead and cost and so on. Do you
see that as a reimbursable item which essentially enables a physi-
cian in his or her clinical practice, and then even the follow-up,
that nurse practitioner calling and asking, "Mrs. Jones, did you un-
derstand what Dr. Gambone talked to you about, and do you need
to speak to him again?" or Dr. Bachmann, or Dr. Carlson— do you
pay for that?

Dr. WroEN. At the present time, we actually do pay for second
surgical opinions, and in many of our contracts, we require it. Our
disappointment has been that oftentimes there is a rather low yield
of disagreement between the first and the second opinion.

Senator Mikulski. Dr. Widen, I'm not talking about a second
opinion. I come to Dr. Carlson, and we agree that I am going to
have a major surgical procedure, a hysterectomy. Would you then
pay for the nurse practitioner to call me after that conversation,
and then also for that pre-op — ^not whether I should have it or
not— because if I don't understand her, I'm not going to understand
the second doc, and the doctor might know more, but I don't know
more. And that's the Gambone study; I need to know more.

Dr. WroEN. We do pay for nurse practitioners who are seeing pa-
tients in physicians' offices, and in some situations we even pay for
nurse practitioners or independent practitioners in rural areas
where there is no other primary care provider of care.

You raise a very, very important point. We feel that high-quality
care mandates that physicians relate to their patients. We feel that
it is an integral part of the surgical procedure for a physician to
sit down with the patient before the surgical procedure and explain
it entirely.

Now, one of the problems that we have faced is that in recent
years there has been an unfortunate trend on the part of many
physicians in the United States to unbundle their charges. In the
past, we used to get a global fee; now, they break it all down. I
have to tell you that that has been a very abusive thing which has
contributed enormously to health care costs, and we have actually
done computer work to offset

Senator Mikulski. What does that mean? Could you give us an
example?

Dr. Widen. That means that a physician — let's take the example
that we're talking about today — will get a bill for a total abdominal
hysterectomy with removal of both tubes and ovaries. There is in
the CPT code a number for that, and that will generate from our
computers a certain payment. But what happened was that the
doctors were then breaking it down. They coded for an abdominal
laparotomy, which means just opening it up; for license of adhe-
sions—they put that CPT code down. Then they put down abdomi-
nal hysterectomy. Then they put down salpingel oophorectomy,
which is taking out the tube and ovaries, on both sides.

Senator Mikulski. Take it easy, because I just asked Dr.
Bachmann to be careful with what we were doing to our recorder.

102

Dr. Widen. And I apologize for getting so emotional about this.
Do you know what happened, Senator Mikulski? The poor com-
puter just added these all up, and the payment to the physician,
instead of being $2,500, would be $8,000 or $9,000. When we be-
came aware of this, what we had to do was to reprogram our com-
puters to tell them that if such-and-such a CPT code came up at
the same time, on the same date, from the same physician, that the
computer was to rebundle and pay under this global code.

Now, this is the sort of thing that I hate to talk about because
I hate to have to tell you that this was becoming a very common
procedure, at least in the State of Illinois, until we cracked down
on it. And I hate to say that physicians were doing it, but that was
a fact, and we have had to correct that.

So I am all in favor of physicians relating to their patients, but
that should be considered an integral part of the surgical proce-
dure.

Senator MiKULSKi. I understand.

I am going to ask two more questions, one of Dr. Gambone and
Dr. Carlson. Dr. Gambone, in your research when you actually
spoke to people about their reasons, their expectations, the reason-
aole alternatives, the risks, and so on, what did you find that they
chose? In other words, did they say, "I'd rather wait it out," if that
seemed appropriate if it were benign? Did they say, "Look, I don't
care. I don t want to hear it anymore. I hurt too much. I bleed too
much. I can't have a proper relationship with my husband. Just fix
it"? How did that work out?

Dr. Gambone. There were a variety of responses. The latter one
you just mentioned certainly occurred. But what was surprising
was the number of patients who really wanted to participate in
making that choice and the number that, when told that watchful
waiting, for example, or expectant management was a reasonable
alternative, they were relieved and wanted to accept that alter-
native.

And it is true that occasionally, after 6 or 8 months of watchful
waiting, a hysterectomy may need to be done; but a surprising
number of women, particularly women in the age group of 44 to 48,
let's say, where ovarian failure may occur in the next 3 to 4 years,
and a uterus which is enlarged with fibroids may stop Rowing on
its own or even decrease in size. So that watchful waitmg in that
situation can be a very reasonable alternative, and many of them
were very surprised that that was an acceptable thing for them to
do.

Senator MncuLSKi. Did they also feel that watchful waiting was
an acceptable alternative because they would have the continuity
of care with somebody named Joe Gambone or Karen Carlson
or

Dr. Gambone. Well, that's a very important point, yes.

Senator Mikulski. — or a George Morley. In other words, they
knew that in 6 months, they had the freedom to come back to a
Dr. Morley or a Dr. Carlson, and they would get the same doctor
who would have the same record, who essentially was watching
with them, who said, "Six months, but if anything changes in 6
days, you call me back," and they knew they would get Dr. Greorge
or Dr. Karen on the phone. Isn't that crucial to that type of care?

103

Dr. Gambone. Absolutely. I think if there is any risk in waiting
that patients want to know that someone is going to be watchfully
following them.

Senator MncuLSKl. But the same person who told them to watch.

Dr. Gambone. Correct. It has to be someone that they trust,
someone that they have this rapport with. That is a very important
point.

Senator MncuLSKi. Which then goes again to the continuity —
much has been said about the doctor-patient relationship, but what
seems to be at the core is to be able to pick your physician and
then be able to maintain a continuity of relationship — not with an
insurance company or an organization, but with that particular
physician.

Some of my pals in my HMO crowd won't go for that, but I think
that is essential, particularly in some of these instances, that
watchful waiting is so crucial.

Dr. Gambone. I agree.

Senator Mikulski. But what we are also saying is that in addi-
tion to science, we need sociological studies, behavioral studies,
even American anthropology studies, because world communities
might need a different type of education and so on.

I also want us to look at something that would not come from
the scientific community — the use of those nonprofit organizations
that interact the most with the American people and interact the
most with women. You heard earlier my comments about the
YWCA and the way they will help us get women to have mammo-

frams and pap smears, will be there for support groups, and will
0 the follow-up, and will watch with them, Dr. Gambone.

You know, we are a very unique society. The nonprofit organiza-
tion is kind of a unique American institution, other than the Red
Cross and the Y, which are worldwide. I happen to believe all of
society profits from the nonprofits, and I think their new, expand-
ing role in service would be tremendous, including the way we will
educate young women, perhaps through Scouts, about themselves,
about a positive image, and then we don't get into sex education
in the schools and so on.

You learn the most from your parents, but you can learn a lot
from other organizations. I also think that holds true for young
men as well.

Well, I have learned a lot from this hearing, and one of the
things that emerges is that we do need more research, not only into
causes, but into outcomes or efficacy. And what is also clear is that
there is not a one-stop shop for efficacy. And I am not going to
mandate one or do legislative initiative, but I'll tell you what I am
going to do. I am going to contact directly Dr. Donna Shalala, the
head of HHS, and in a very positive way, talk about this hearing
and the need for the kind of across-the-board, the varied type of re-
search fi^om the clinical trial to the kinds of research that have
been indicated in these panel — we all know what NIH and FDA
do — ^but research that is focused on efficacy, the patients them-
selves, the best way to empower patients, what are other institu-
tions that could encourage more effective utilization — that keeping
your appointment would be pretty important, to do the follow-up,
and so on.

104

So I am going to write to Dr. Shalala and ask her to examine
within the agency itself what is the best place to have the research
or at least wr the efficacy work to be done, if it's not a one-stop
shop that does the efficacy that at least there be a one-stop shop
where all of the information could come in from the FDA, the Insti-
tutes, the CDC, on these issues, particularly those that are some
of the highest utilization medical and surgical procedures. Do you
think that's a good idea — because we are here not equipped to draw
boxes on organizational charts, and that's not what we are all
about. We want you to be able to know, and we want the patients
to know when we'll be able to work on it.

Well, we thank you. The red light and the white light are on, and
that means I've got to get moving.

I want to thank this panel and the previous two for their out-
standing testimony, and I will tell you it will not be another 20
years before we hold another hearing, and hopefully, our next hear-
ing will be the results of the Bachmann clinical trial or the clinical
trials on what we know about efficacy.

Thank you so much. This subcommittee stands in recess subject
to call of the chair.

[Additional material follows:]

105

Additional Material

Unnecessary Hysterectomies, the Second Most Common Major Surgery in

THE United States— May 1993

Prepared by StafTof the Subcommittee on Aging
SCOPE OF THE PROBLEM

Last year over half a million women in the United States underwent a hyster-
ectomy. These women — ^the majority of whom are between the ages of 40 and 44 —
join the nearly 7 million women that underwent hysterectomy between 1981 and
1991.

The rate of hysterectomy has decreased since the 19708 when hysterectomy was
the most common surgical procedure performed in the U.S. Today, hysterectomy is
the second most common major surgery performed — second only to caesarean sec-
tion. The actual number of hysterectomies performed is expected to rise, however,
if current rates continue, because the postwar "baby boom" generation has reached
the ages when hysterectomies are most likely to be performed. By 1995, the number
of hysterectomies is expected to reach 783,000, and by the year 2005, it is expected
to rise to 824,000. [1]

Today, one out of every three women can expect to have a hysterectomy by the
time she reaches the age of 60. The annual direct costs for the operation currently
exceed $5 billion alone.

professional uncertainty regarding hysterectomy

A closer look at the hysterectomy rate in the United States shows that it varies
significantly according to geography and race. Hysterectomy rates appear to be the
highest in the South and Midwest. Hysterectomy is more often performed in blacks
than in whites, and in women of lower socio-economic status — although hospital dis-
charge data does not always reflect differences in race and income. And according
to some studies, hysterectomy is performed more often by male gynecologists. [2]

The "primary cause of the variation in rates," of hysterectomy ticcording to a re-
cent study in the New England Journal of Medicine, is "professional uncertainty
about the appropriate use of hysterectomy."

The study found that indications for hysterectomy, or the appropriate conditions
for recommending or performing a hysterectomy, "have not been well established"
because of gaps in research and "the lack of data on the outcomes of hysterectomy
and of alternative medical and surgical treatments for such conditions."

Other researchers have raised concerns about the appropriate indications for hys-
terectomy, especially when hysterectomy is done in asymptomatic or minimally
symptomatic women without life-threatening conditions.

The American College of Obstetricians and Gynecologists (ACOG) publishes guide-
lines on the appropriate use of hysterectomy throughout the country. These guide-
lines came under scrutiny by AC50G in the 1980s when criticism arose about the
high rates of hysterectomy and about the significant regional variation that contin-
ues today. In 1987, ACOG formed a task force on hysterectomy. The task force never
published its findings. The unpublished document, however, concludes that "most
hysterectomies are performed for well documented indications and in accordance
with quality assurance guidelines. Nevertheless, there are some cases where consen-
sus is lacking and where physicians must rely on their own individual clinical judg-
ment.

Many researchers continue to believe, however, that because of the lack of suffi-
cient research on conditions leading to hysterectomy and on the outcome of hyster-
ectomy itself physicians today lack sufficient information regarding the appropriate
reasons to recommend hysterectomy, the outcomes and complications of hyster-
ectomy, and alternative treatments for hysterectomy. Women facing the decision to
have a hysterectomy — must also do so with incomplete information.

THE LACK OF RESEARCH

Basic Research

The indications for hysterectomy have changed over the years. One of the major
reasons established for performing hysterectomy in the past— the prevention of uter-
ine and cervical cancer — no longer is thought sufficient in itself to justify hyster-
ectomy.

The vast majority of hysterectomies today are performed for benign conditions
such as fibroid tumors, endometriosis, and dysfunctional uterine bleeding. Some re-
searchers consider that as many of 90 percent of the snideries performed today are

106

"elective," or surgery performed for nonlife threatening conditions. These condi-
tions— which can be pnysicallv debilitating, cause enormous pain and signiiicant
disruption to a woman's life — have received pitifully little attention by medical re-
searchers.

NIH is spending less than $1 million in fiscal year 1993 on studies of fibroid tu-
mors and endometriosis. Yet endometriosis and fibroid tumors account for approxi-
mately 50 percent of all hysterectomies, that add billions of dollars to the cost of
the health care system.

Moreover, little is known about what causes these conditions and other
nonmalignant disorders that often lead to hysterectomy.

Endometriosis: According to the Endometriosis Association, endometriosis af-
fects approximately 5 million of women in the United States. Endometriosis oc-
curs when tissue normally located in the uterus is found in other parts of the
body, usually the abdomen, resulting in internal bleeding, scar tissue, inflam-
mation, and other medical problems.

Fibroid Tumors: Uterine fibroid tumors are estimated to affect 30 to 50 per-
cent of all women. Fibroids are noncancerous tumors that grow on the uterine
wall. Fibroids can range from the size of a pinhead to larger than a grapefruit,
and may cause no symptoms at all. When they are symptomatic, fibroids can
cause abnormal bleeding, abdominal swelling, infertility, pelvic or back pain,
constipation, or severe menstrual cramps.

Dysfunctional Uterine Bleeding: This is a diagnosis of exclusion, referring to
abnormal bleeding that is not attributable to other causes. Dysfunctional uter-
ine bleeding has been estimated to account for approximately 20 percent of
hysterectomies in the U.S.

Uterine Prolapse: Prolapse is a weakening of the ligaments that keep the
uterus in place, causing it to fall. Prolapse accounts for approximately 15 per-
cent of hysterectomies in the U.S.

Chronic Pelvic Pain: Chronic pelvic pain, which refers to pain that cannot be
traced to a specific disease, is a little-understood disorder that accounts for ap-
proximately 10 percent of all hysterectomies.

Outcomes Research

Even though hysterectomy is so commonly performed in the United States, there
has not been sufficient research to measure the success of hysterectomy— or alter-
natives to hysterectomy — for treating these conditions.

The Agency for Health Care Policy and Research (AHCPR) has undertaken three
small studies to look at the effectiveness of hysterectomy. These studies, in Maine,
Maryland, and California, will be the first of their type to look at long and short
term outcomes of hysterectomy. They will provide information on the decision-mak-
ing process, physical and psychological outcomes of hysterectomy, and the effective-
ness of hysterectomy compared to medical and surgical alternatives.

These studies, however, are very limited. The study populations are very small —
the Maryland site, the largest of the three studies, will enroll only 1,300 women.
The CaUfomia site is studying upper middle class women aged 50 to 89. Also, the
"long-term outcomes" do not extend beyond 4 years for any of the studies, so infor-
mation on the effect of hysterectomy as women age will not be available.

Almost twenty years after congress first looked at this problem of unnecessary
hysterectomy, no clinical trial has ever been done to evaluate the effectiveness of
hysterectomy or to determine the appropriate rate of hysterectomy. Clinical trials
have been successfully used for less common medical procedures, such as treatment
of myocardial infarction, and have resulted in changes in clinical practice worldwide.

A cUnical trial could determine the appropriate indications and rate for hyster-
ectomy, evaluate the effectiveness of hysterectomy and alternatives, and would ob-
jectively study the medical, psychological, and overall Quality of life outcomes of
women who undergo hysterectomy. Information provided by a clinical trial would
allow more informed choices to be made by patient and physician regarding the cir-
cumstances where hysterectomy is the treatment of choice. [3]

COMPLICATIONS OF HYSTERECTOMY

The frequency of hysterectomy would lead one to assume that it is a safe and effi-
cient procedure. Surgical advances of this century have simplified the procedure and
have reduced the death rate from complications of hysterectomy from approximately
90% of all operations in the 19th century to approximately 12 per 10,000 surgeries
today. The average length of hospital stay has also been reduced in recent years,
from 12.2 days in 1965 to 5.7 days in 1987. [4]

107

Despite these advances, however, up to one half of all women undergoing hyster-
ectomy experience complications, and up to 15 percent will need a secona sui^ery
for complications related to the original operation. Hysterectomy is a major surgical
procedure, and carries with it the risk of complications from anesthesia, hemor-
rhage, infection, surgical damage to other organs, and nerve destruction. Between
8 and 15 percent of women undergoing hysterectomy require blood transfusions, and
nearly one-third will have a high fever as a result of surgery. [5]

Hysterectomy and oophorectomy (removal of the ovaries) may also result in a host
of psychological problems, including depression, mood swings, memory loss, fatigue,
and decreased sex drive. Some estimates show that as many as 70 percent of all
women undergoing hysterectomy will have negative psychological consequences.
Nevertheless, many women are not told about these consequences prior to sui^ery.
In addition, there is little information on a woman's likelihood of experiencing psy-
chologic£d complications after hysterectonw. [6]

Even without complications, a woman faces between five two 7 weeks of recovery
at home after hysterectomy, and possibly several weeks beyond that to become fully
functional and resume regular activities. For a woman with even a moderately ac-
tive lifestyle, recoveiy from hysterectomy alone can be a major burden.

REDUCING UNNECESSARY HYSTERECTOMY

Some efforts have been made to decrease the rates of unnecessary hysterectomy
in the U.S. Two recent studies and recent legislation strongly suggest that the large
number of hj'sterectomies performed in the United States is unnecessary.

Blue Cross and Blue Shield of Illinois (BCBSI), which insures 22% of Illinois resi-
dents, found that one-third of the 5,844 hysterectomies performed in the State be-
tween 1987 and 1989 were unnecessary. The study founcf the largest number of un-
necessary hysterectomies in women under 40 for fibroids, prolapse, and chronic pel-
vic pain. This led BCBSI to put in place an auditing program to reduce unnecessary
hysterectomies in the State. [7]

Another study found that hysterectomy rates dropped by 24 percent over a 5 year
period in a hospital that usedi rigorous criteria to justify hysterectomy prior to sur-
gery as part of a quality assurance program. [8]

In response to the high number of questionable hysterectomies in the State, Cali-
fornia passed a law in 1987 that requires a doctor to get verbal and written in-
formed consent from a patient prior to performing a hysterectomy. The law also re-
quires that the patient be given explicit written «md verbal information about hys-
terectomy, including a description of all procedures involved in the operation, such
as oophorectomy, altematives to hysterectomy, expected benefits of nysterectomy,
risk for complications, recovery time, and financial cost. A physician who does not
obtain informed consent under this law would be cited for unprofessional conduct,
and the penalty that would result, if any, is unclear. [9]

Efforts to reduce the rate of hysterectomy by third party payers — without ade-
quate research on the conditions that lead to hysterectomy or alternative treat-
ments— may reduce the choice of patients for obtaining such procedures. Nonethe-
less, such studies point out the need for further research.

ALTERNATIVE TREATMENTS TO HYSTERECTOMY

There are other medical or less invasive surgical altematives to hysterectomy for
every nonmalignant condition for which hysterectomy is performed. ACOG rec-
ommends that hysterectomy be the last resort after alternative treatments have
been attempted. Altematives to hysterectomy include medical therapies such as hor-
monal treatments and painkillers, and surgery such as endometrial ablation, which
is the removal of the lining of the uterus by laser, which is used for endometriosis,
and myomectomy, which is the surgical removal of fibroids. "Watchful waiting" is
a nonmedical alternative to hysterectomy that may be effective for conditions such
as fibroids, dysfunctional uterine bleeding, and endometriosis, especially if symp-
toms are oiild, since these conditions usually subside after menopause. [10]

However, medical and surgical altematives to hysterectomy nave not undergone
serious medical evaluation to determine their effectiveness, nor have they been thor-
oughly compared to hysterectomy. Alternative treatments may be costly, may cause
severe complications and side effects, and may have to be repeated or combined with
other treatments without any guarantee of cure.

ACOG recommends that full information be given to patients on hysterectomy and
altematives; however, not all women are told about all options available. This hap-
pens because medical practice has traditionally emphasized hysterectomy to treat
persistent gynecological problems, tmd when faced with a little -understood condi-
tions, physicians often resort to what their medical education has taught them.

108

Some alternatives require additional training and are not used by all gynecologists,
and physicians may not be aware of newer methods.

ATTITUDES ABOUT HYSTERECTOMY

The attitude guiding the recommendations for hysterectomy have in some ways
remain unchanged: women don't need a uterus after they have completed their fami-
lies.

Yet so little research has been done on the normal human aging in women and
the effect of the reproductive system, the uterus and ovaries, that it is time to chal-
lenge these assumptions and scrutinize the appropriateness of hysterectomy itself.

For non life-threatening conditions, it appears that hysterectomy is performed
more out of folklore amd tradition than proven effectiveness. When it comes to these
conditions, hysterectomy may result in substituting one set of problems for another
that is far more detrimental. Hysterectomy is portrayed as routine and without con-
sequence, but this is not always the case. Hysterectomy is a costly procedure, in
terms of direct and indirect coats, the complication rate is substantial, and since
hysterectomy is emphasized as the standard medical practice, when patients decide
to have a hysterectomy they may not be fiiUy informed about the range of alter-
natives available.

Moreover, despite the high frequency, cost, and available alternatives, there have
been few studies examining hysterectomy in detail. This includes research on the
natural history of the indications that lead to hysterectomy, long-term patient out-
comes studies, studies on the effectiveness of the surgical procedure in terms of re-
lieving symptoms and improving quality of life, studies comparing hysterectomy
with available medical and surgical alternatives, and studies of the long-term health
effects of hormone replacement therapy.

These remaining questions warrant further research to better our understanding
of the uterus, ovaries and fallopian tubes and the development of technologies that
may preserve them, it may be that the avenues of research into these questions
have been limited by years of neglect of women's health care issues. However, when
such basic information on the second most common surgery performed in the United
States is lacking, it is obvious that the time to take another look at this procedure
is now.

Perhaps equally important, we must revise our belief systems about the female
reproductive organs, especially the belief that the uterus and ovaries are unimpor-
tant after childbearing. Such changes are essential for the health and well-being of
our mothers, ourselves and our dau^ters.

SOURCES CITED

1. National Center for Health Statistics. Hysterectomy: past, present, and future.
Statistical Bulletin 1989:12-21.

2. Carlson KJ, Nichols DH, SchifT I. Indications for hysterectomy. New England
Journal of Medicine 1993;328(12):856-860.

3. Bachmann GA. Hysterectomy: is there a need for a clinical trial? Maturitas
1992; 15:3-6.

4. National Center for Health Statistics. Hysterectomy: past, present, and future.
Statistical Bulletin 1989:12-21.

5. Wolfe SM. Women's health alert. New York, Addison-Wesley Publishing Com-
pany, 1991.

6. Goldfarb HA. The no-hysterectomy option: your body-your choice. New York,
John Wiley and Sons, 1990.

7. Blue Cross and Blue Shield of Illinois. Hysterectomy at Illinois hospitals: poten-
tial for eliminating unnecessary surgery. Blue Cross and Blue Shield of Illinois
Health Services Research May, 1990.

8. Gambone JC, Reiter RC, Lench JB, Moore JG. The impact of a quality assur-
ance process on the frequency and confirmation rate of hysterectomy. Am J Obstet-
rics and Gynecology 1990; 163(2):545-550.

9. State of California Senate Bill Number 835.

10. Wolfe SM. Women's health alert. New York, Addison-Wesley Publishing Com-
pany, 1991.

109

Hysterectomy at Illinois Hospitals — May 1990
potential for eliminating unnecessary surgery

Introduction

Hjrsterectomies tire performed frequently and often without appropriate justifica-
tion. Patterns of practice related to hysterectomy vary from region to region. The
hospital and professional care associated with this procedure is costly. It is a major
surgical procedure with the risk of medical complications and. psychological
sequelae.

Eliminating unnecessary hysterectomies by ensuring their appropriate use and by
reducing regional variation in practice patterns will serve the best interest of every-
one, from the women who may be subjected to unnecessary pain and illness to em-
gloyers who may be responsible for the associated dollar costs. To that end, Blue
ross and Blue Shield oi Dlinois (BCBSI) has completed a study of recent medical
literature and inpatient claims data related to hysterectomy.

Correspondence with the hospitals in Dlinois regarding their own BCBSI patient
care experience with hysterectomies wiU follow this study. This corrfjspondence will
include reports of individual hospitals' hysterectomy experience w-tn BCBSI pa-
tients and will initiate a dialog on the topic of hysterectomies. The correspondence
will culminate with the completion and return of a survey focused on individual hos-
pitals' gynecology protocols, quality review procedures, and potential problems with
the use of hysterectomy. This dialog will form the basis for a positive, cooperative
approach to the reduction of unnecessary hysterectomies in Illinois.

Trends at BCBSI Compared to National Trends

Hysterectomy is the second most frequently performed surgical procedure in the
United States after cesarean section.

Similarly, hysterectomy is the second most frequently performed surgical pro-
cedure among the population covered by BCBSI (an average of 2.29 million indi-
viduals in 1989), after cesarean section. Approximately 4,600 hysterectomies
were performed on women covered by BCBSI in 1989. That figure represents
approximatelv 2.3 percent of all inpatient admissions, or 2.02 admissions per
1,000 covered lives (total male and female population).

The rate of hysterectomies rose and peaked nationally during the mid-19708, then
declined and leveled off during the early 1980s. Throughout the 1980s the national
rate has remained in the range of 5.5 to 7.0 hysterectomies per 1,0(X) women.

The rate of hysterectomies for women covered by BCBSI in 1989 was 5.7 per
1,000 adult women. This figure includes employed female and female spouses;
it excludes hysterectomies for depeiidents. Dependents were also excluded from
the calculation of adult female membership. Dependents accounted for only 0.15
percent of all hysterectomies.

The average billed hospital charge for a hysterectomy in 1989 was $6,526,
and the average combined physicians' (attending, anesthesiologist, assisting)
bUled charge per hospitalization was $3,581. The average combined billed
charge for hospital and physician services for hysterectomy amounted to
$10,107. Based on 4,625 admissions for hysterectomy in 1989, total billed
charges amounted to approximately $46.8 million.

Inappropriate Reasons for Hysterectomy

Hysterectomy is rarely appropriate for chronic pelvic pain or pelvic congestion
syndrome. Hysterectomy should not be performed as prophylaxis against cancer, for
contraception in a gynecologically normal patient, for management of the meno-
pause, for chronic cervicitis, for primary dysmenorrhea, for premenstrual tension,
for nuld urinary incontinence, for a single episode of postmenopausal bleeding, for
an abnormal Pap smear report, or for mild or moderate cervical dysplasia. Practi-
tioners sometimes attempt to justify hysterectomy by combining several inappropri-
ate indications, any one of which would not justify the hysterectomy alone. Combin-
ing inappropriate indications to justify hysterectomy does not constitute appropriate
practice. Instead, each indication should be treated individually.

Cost Implications

As discussed above, medical research indicates that clear reasons for the perform-
ance of hysterectomies exist, but hysterectomies are still performed unnecessarily.
Some researchers indicate that as many as 30 percent to 44 percent of
hysterectomies are unnecessary. High costs compel the elimination of these unneces-
sary hysterectomies, but costs should not be measured in dollars alone. Dollar

110

amounts define direct costs. They are easily measured. The costs of the hospital care
and the professional services related to the hysterectomy itself are direct costs. Indi-
rect costs are more difficult to measure. Disruption oi normal daily activities and
normal health define indirect costs. Additional dollars spent because of those disrup-
tions also figure into the calculation of indirect costs. They may be borne by the in-
dividual ana by business, and they compound the more obvious direct costs.

Indirect individual costs may be measured in unexpected Ulness and suffering. Re-
searchers estimate that 25 percent to 50 percent of all hysterectomies result in com-
plications. Even though some of those complications may be mUd and easily treated,
they generally result in more illness and suffering for the individual, mdividual
costs may also be measured in psychological symptoms. Many researchers have
linked hysterectomy to depression. Besides depression, hysterectomy may disrupt a
woman's feminine identity. For some women, loss of the uterus may equate to a loss
of femininity. In addition to the direct costs of hospitalization and sui^cal care,
then, hysterectomy carries the risk of costs that may result from medical complica-
tions, depression, and alteration of feminine identity.

Indirect business costs may be measured in absenteeism and the consequent re-
duction of productivity of employees receiving hysterectomies. Business may also
bear the cost of providing disability coverage to those employees during the con-
valescent period in addition to tiie health care benefits that covered the cost of the
hospitalization. The indirect costs to business generally can be measured in dollars
or in the loss of productive days due to absenteeism. On the whole, the indirect busi-
ness costs of hysterectomy may be substantial.

Regional Variations

Studies have shown that hysterectomy rates vary by region. Any attempts by
BCBSI to study and eliminate unnecessary hysterectomies at the State level should
focus on regional and institutional variations in the rates and performance of hys-
terectomy. A study of nearly 6,000 inpatient claims related to inpatient admissions
for hysterectomy was conducted by BCBSI. This study was basea on claims submit-
ted by Illinois hospitals and processed by BCBSI during the three-year period from
1987 through 1989. It revealed that admissions for hysterectomy accounted for near-
ly half (48.1 percent) of aU admissions for female reproductive disorders. Nearly 10
percent of the hysterectomies were j>erformed to treat malignancy of the female re-
productive organs. Thirty percent of all hysterectomies were performed to treat
nonmalignant diseases for women under the age of 40, and the remaining 60 per-
cent were performed to treat nonmalignant diseases for women aged 40 and over.

BCBSI Study of Hysterectomy in Illinois 1987-89

Admissions for Female Reproductive Disorders (Study Sample) 12,139

Total Hysterectomies 5,844

As Percentage of Admissions for Female Reproductive Disorders 48.1%

Hysterectomies to Treat Malignancy 573

As Percentage of All Hysterectomies 98%

Hysterectomies to Treat Non-Malignant Diseases, Under Age 40 1,759

As Percentage of All Hysterectomies 30.1%

Hysterectomies to Treat Non-Malignant Diseases, Age 40 and Over 3,512

As Percentage of All Hysterectomies 60.1%

Opinion varies regarding the necessity of hysterectomy to treat normialignant dis-
eases. Particular concern has been expressed regaroing hysterectomy to treat
nonmalignant disease for women in the child-bearing years (up to age 40). AS
shown above, hysterectomies for that particular group accounted for 30 percent of
all hysterectonues. TTiat proportion varied throughout the State according to hos-
pital size and geographic location. It ranged from 24 to 45 f>ercent of all
hysterectomies. The ten hospital categories with the largest percentage of
hysterectomies for nonmalignant diseases in women under age 40 are listed below:

Hysterectomy
for

Hospital Cetegoty (Over 75 Hysterectomies 1987-«) 'dIsmmI^?

40 as % All
Hysterectomies

West Ontral Illinois Over 100 Beds 45.0

Southern Illinois Over 100 Beds 40.7

North/North Central lllinois>100 Beds 39.8

North/North Central lllinois>200 Beds 39.5

East Central Illinois Over 200 Beds 37.6

Ill

for
Hospitil C»t»|0(y ((Ker 75 HysterectomiM 1987-89) "dSJ^'m I^S'

40 as % All
HystsrectoniM

Inner City Non-Teaching>150 Beds 36.0

Five County Under 200 Beds 36.0

Southwest Illinois Over 100 Beds 34.6

Northwestern Illinois Over 100 Beds 33.2

S.W. Cook/Will/Grundy/Kankatee Counties 33.1

Sumary

Recent medical literature indicates that many hysterectomies are performed un-
necessarily. Secause the rate of hysterectomies among women covered by BCBSI
does not difFer substantially from that of the general female population of the Unit-
ed States, one may reasonably conclude that hysterectomies are also performed un-
necessarily on those women covered by BCBSI. The medical literature also indicates
that clinical practice related to this procedure varies from region to region. BCBSI
data indicate that the use of this procedure, especially for women under the age of
40 without malignant disease, varies within the State of Dlinois, as well.

Sheer numbers compel careful study of this clinical issue: it is the second most
frequently performed surgical procedure in the United States and for BCBSI pa-
tients in Illinois. The dollar cost resulting from the hospital and physician care of
the 4,600 BCBSI patients submitting claims for hysterectomies in 1989 hovered at
an estimated $46 million. The indirect costs for those hysterectomies were less tan-
gible but no less significant. They may have been defined by the additional risk of
unexpected complications and illness, by personal pain and suffering, by days con-
fined in the hospital and at home, by psychological disequilibrium, by diminished
productivity in the workplace, and by costs to business for disability coverage.

Through this study, throu^ individual reports to Illinois hospitals, and through
surveys of hospitals' experience with this clinical issue, BCBSI has initiated a coop-
erative program to reduce the incidence of unnecessary hysterectomies and the asso-
ciated costs in Illinois.

Hysterectomy at Illinois Hospitals— December 1992

A CLI^aCAL review of procedures performed on women ages 20-40

Introduction

Second to Caesarean sections, hysterectomies are the most frequently performed
surgical procedures. By the time they reach 60, more than 35% of the women in
America nave had a hysterectomy. The majority of hysterectomies are performed on
patients between the ages of 30 to 49.

Study Metfiods

In a follow-up to its 1990 study of hysterectomy, the Health Services Research di-
vision of Blue Cross and Blue Shield of Illinois undertook a review of hospital ad-
missions for hysterectomy.

First, a sample of hospital claims data for 1990 and 1991 was reviewed for the
following:

age distribution of hysterectomy patients

rate of malignant versus nonmalignant diagnoses

distribution of hysterectomy by hospital.

The sample was drawn from one of the company's large databases, representing
an estimated 600,000 lives.
During the initial stage of the study, researchers found:
Women aged 40 to 49 accounted for nearly half of all hysterectomies performed
on BCBSI patients during 1990 and 1991;

For Doth sampled years, more than 90% of hysterectomies were performed for
the treatment oi nonmalignant conditions;

Hysterectomy admissions were widely scattered among several hospitals pre-
dominantly located in the Chicago metropolitan area.

The initial review led to a decision to conduct a clinical analysis of the 764
hysterectomies in the study sample performed on women with nonmalignant condi-
tions between the ages of 20 and 40, to determine if they were medically appro-
priate.

112

Dlinois hospitals were contacted, and asked to randomly select approximately 33%
of the cases of hysterectomy performed in their institutions on women between the
ages of 20 to 40 for benign conditions. 114 records were sent to Blue Cross and Blue
shield of Illinois. Once uie diarts were received by Health Services Research, they
were logged and reviewed by nurse reviewers for medical necessity.

The charts that either failed to pass the appropriateness test for medical necessity
or in which the documentation was inconclusive, were passed along to the Medical
Department for further review.

Concurrent with the request for hospital inpatient records, a random sample was
selected of the office records of physicians who performed hysterectomies. Those
records were subjected to the same review for medical appropriateness.

Results

The results of the hospital chart review are as follows:

114 charts were initially reviewed by the nurse reviewers;

67 hysterectomies were determined to be inappropriate by the nurse review-
ers and forwarded to the Medical Department for review;

Of the charts forwarded to the Medical Department, 61 were reviewed; 11
were considered appropriate hysterectomies and 50 were determined to be inap-
propriate;

One adinission was a result of a patient request for a hysterectomy;

With the elimination of the approved hysterectomies and the cases with insuf-
ficient data, 33.3% of the admissions for nonmalignant hysterectomies for pa-
tients between the ages of 20 and 40 were determined to be inappropriate;

With approximately 764 hysterectomies performed for nonmalignant condi-
tions (for women between the ages of 20 and 40) in 1990 and 1991, at an aver-
age charge per surgery of $11,303, the number of medically inappropriate proce-
dures (excluding those with insuflicient information) represented $2,875,618 in
health care charges.

The results of the physician office chart review are as follows:

Of the 36 charts received from physician offices, 10 hysterectomies (27.8%)
were identified by the nurse reviewers as medically inappropriate, 7 (19.4%)
were indeterminate and 19 (52.8%) were identified as inappropriate;

As with the hospital inpatient records, the inappropriate and indeterminate
records were forward to the Medical Department for evaluation;

The Medical Department review found three appropriate hysterectomies and
23 inappropriate procedures;

17 of the 23 inappropriate hysterectomies, or 73.9% of all the charts referred
to the Medical Department for review, were labeled inappropriate because of in-
sufficient information in the physicians' records.

113

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[Whereupon, at 4:50 p.m., the subcommittee was adjourned.]

68-667 (128)

BOSTON PUBLIC LIBRARY

3 9999 05982 534 7

ISBN 0-16-041440-7

9 780160"414404

90000

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Full text of "Unnecessary hysterectomies, the second most common major surgery in the United States : hearing before the Subcommittee on Aging of the Committee on Labor and Human Resources, United States Senate, One Hundred Third Congress, first session ... May 5, 1993"

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